Medical imaging methods using multiple arrays

Abstract

Disclosed herein is a system and method for visualizing a target anatomical part of a patient using one or more imagers. The method may include placing multiple imagers at multiple locations at the anatomical part. The method may also include: generating separate image data sets based on the multiple images, and combining the image data sets to generate volumetric imaging data of the anatomical part. The volumetric imaging data may include all anatomical features within the target anatomical part. A visualization system for medical imaging may include a transducer on the imager to visualize the target anatomical part. The system may also include a processor to combine the image data sets to generate a volumetric imaging data set. The system may also include a display device to display the volumetric imaging data set.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of the filing dates of U.S. Provisional Application No. 62 / 678,885, filed on May 31, 2018, U.S. Provisional Application No. 62 / 678,868, filed on May 31, 2018, and U.S. Provisional Application No. 62 / 678,854, filed on May 31, 2018, the disclosures of which are incorporated herein by reference in their entireties. Technical Field Background Art

[0003] Insertion of intravenous needles and cannulas is one of the most widely performed medical procedures in modern medicine, whether for drawing blood, administering drugs or other compositions, etc.

[0004] Although widely used in many applications, inserting needles and cannulas into a patient's circulatory system (e.g., blood vessels, veins, arteries, microvasculature, etc.) is an inexact science that often relies on the experience of the user or operator (e.g., physician, nurse, phlebotomist, technician, etc.) to locate hidden and unstable targets, which in some cases may require multiple attempts. This operational imprecision leads to patient fear, discomfort, and potential mental and / or physical trauma.

[0005] In recent years, there have been many attempts to modernize the process by introducing automation and imaging and computerized assistance and distraction from pain. However, particularly with respect to imaging and automation, the resulting concepts and designs have proven to be non-intuitive for the operator, cumbersome, and in many cases, as inaccurate and unpredictable as conventional methods. Therefore, there is a need for an improved device that provides greater accuracy in needle placement while also having a manageable design and size for simplified use by operators, including less experienced and skilled operators.

[0006] Visualization of body regions is a key requirement for successfully diagnosing various medical diseases and / or performing various surgical procedures. Complex and expensive visualization equipment (such as current ultrasound imaging systems) limits or prevents the use of three-dimensional visualization for many surgical applications. For example, although widely used in many applications, inserting needles and cannulas into a patient's circulatory system (e.g., blood vessels, veins, arteries, microvasculature, etc.) is an inexact science that typically relies on the experience of the user or operator (e.g., doctor, nurse, phlebotomist, technician, etc.) to locate hidden and unstable targets, which may require multiple attempts in some cases. The imprecision of this operation causes fear, discomfort, and potential mental and / or physical trauma to the patient.

[0007] The imprecision of this operation can be enhanced by certain characteristics of the patient's circulatory system. For example, blood vessels are often superficial, small, and mobile. In addition, blood vessels can be blocked by bones or tissue during computerized imaging, resulting in incomplete volumetric cardiac images. Such characteristics can make the image data set less robust and less reliable, thereby increasing the risk of inaccuracy.

[0008] In recent years, there have been many 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, are only as inaccurate and unpredictable as conventional methods. Furthermore, current visualization devices suffer from an inability to adequately image anatomical structures that may be hidden by dense structures (such as bone), which can hinder the operator's ability to obtain a clear image of the target anatomical structure, resulting in inappropriate operation.

[0009] Therefore, there is a need for an improved visualization device that provides real-time three-dimensional visualization of a body region for use in medical diagnosis and / or performing medical procedures. Summary of the invention

[0010] The present disclosure generally relates to visualization techniques typically associated with devices used in medical procedures. Specifically, the present disclosure relates to such devices that can perform a variety of functions, including, for example, locating a potential intravenous puncture site on a patient, navigating and manipulating a needle or cannula to the located puncture site (which can include fine-tuning or automatically correcting the position and / or trajectory of a manually or semi-manually inserted needle or cannula through a target and / or needle stabilization), and moving the needle or cannula into and 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 anatomical structure from different locations using triangulation. Specifically, if anatomical features (e.g., bone, tissue) block 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 anatomical structure for needle insertion.

[0011] In a first aspect of the present disclosure, a method for medical imaging using multiple imagers is provided. The method may include the following steps: placing a first imager at a first position relative to an anatomical part, placing a second imager at a second position relative to the anatomical part, generating a first volume image dataset using the first imager, generating a second volume image dataset using the second imager, and combining the first volume image dataset and the second volume image dataset to generate a third volume imaging dataset of the anatomical part. The third volume imaging dataset of the anatomical part may include all anatomical features within the volume defined by the volume imaging data.

[0012] According to the first aspect, the anatomical feature may include hard tissue and soft tissue.

[0013] According to the first aspect, the method may comprise the step of displaying the third volumetric imaging dataset on a display screen.

[0014] According to a first aspect, the first imager can be on a first plane in a first position. The second imager can be on a second plane in a second position. The first plane and the second plane can be on opposite sides of the anatomical site.

[0015] 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 site may further comprise the step of combining volumetric image data from the third image data set and the fourth image data set.

[0016] In a second aspect of the present disclosure, a medical imaging system is provided. The medical imaging system may include a first imager, a second imager, a processor, and a display device. The first imager may be configured to generate a first image data set of an anatomical part at a first position. The second imager may be configured to generate a second image data set of an anatomical part at a second position. The processor may combine the first image data set with the second image data set to generate a volume image data set. The display device may display the volume image data set. The volume imaging data set of the anatomical part may include all anatomical features within a volume defined by the volume imaging data set.

[0017] According to a second aspect, a display device may include a plurality of screens. Each screen may be perpendicular to at least one other screen.

[0018] According to a second aspect, the first imager may have a length and a width defining a first footprint. The second imager 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, the width and the depth.

[0019] According to a second aspect, the volumetric imaging data may display all anatomical features within the volume.

[0020] According to a second aspect, anatomical features occluded by bone in the first image data may be captured by the second image data.

[0021] In a third aspect of the present disclosure, a medical imaging system is provided. The medical imaging system may include an imager and a transducer array. The imager may be configured to generate a volume image data set of an anatomical part. The transducer array may be located on a distal surface of the imager. The array may have a length and a width defining a first footprint. The array may generate a volume image data set. The volume image data set may be defined by a volume defined by a length, a width, and a depth. The volume imaging data set of the anatomical part may include all anatomical features within the volume.

[0022] In a fourth aspect of the present disclosure, a medical imaging system is provided. The medical imaging system may include an imager and a transducer array. The imager may be configured to generate a volume image data set of an anatomical part. The transducer array may be located on a distal surface of the imager. The array may have a length and a width defining a first footprint. The array may generate a volume image data set. The volume image data set may be defined by a volume defined by a length, a width, and a depth, so that all anatomical features within the volume are contained in the volume image data set.

[0023] In a fifth aspect of the present disclosure, a medical imaging system is provided. The medical imaging system may include an imager, a first transducer array and a second transducer array. The imager may be configured to generate a volumetric image data set of an anatomical part. The first transducer array may be located on a surface of a first plane of the imager. The first array may have a first length and a first width defining a first footprint. The second transducer array may be located on a surface of a second plane of the imager. The second array may have a second length and a second width defining a second footprint. The surface of the first plane may be inclined and away from the surface of the second plane to define a gap between the surface of the first plane and the surface of the second plane. The projected area of ​​the first footprint and the projected area of ​​the second footprint may intersect so that the volume below the gap is included in the volumetric image data set generated by the imager.

[0024] In a sixth aspect of the present disclosure, a medical imaging system is provided. The medical imaging system may include an imager, a first transducer array, and a second transducer array. The imager may be configured to generate a volumetric image data set of an anatomical part. The first transducer array may be located on a first surface of the imager. The first array may define a first footprint. The second transducer array may be located on a second surface of the imager. The second array may define a second footprint. The first surface may be separated from the second surface to define a gap between the first surface and the second surface. The projected area of ​​the first footprint and the projected area of ​​the second footprint may intersect, so that the volume below the gap is included in the volumetric image data set generated by the imager.

[0025] In a seventh aspect of the present disclosure, a method for medical imaging using an imager is provided. The method may include the following steps: placing an imager adjacent to an anatomical part, the imager including a plurality of transducers, the plurality of transducers defining an area defined by a length and a width, the anatomical part including hard tissue and soft tissue, the hard tissue being located between the imager and the soft tissue, the hard tissue including one or more gaps; generating an image data set based on signals transmitted and received by each of the plurality of transducers, and generating a volumetric image data set by combining the image data sets, the volumetric image data set being defined by a volume defined by an area and a depth, so that the hard tissue and the soft tissue are included in the volumetric image data set. The signal transmitted by each of the transducers directly above the hard tissue may propagate through the gap and diverge to contact the soft tissue.

[0026] According to a seventh aspect, the hard tissue may be bone and the soft tissue may be an organ.

[0027] According to a seventh aspect, the propagated signal may collect data of all or substantially all of the soft tissue.

[0028] According to a seventh aspect, the imager may include a display screen that displays the volumetric image data set. A display may be coupled to the imager. The display may include a parallax display for moving the volumetric image data set relative to an operator's line of sight. The parallax may allow an operator to view portions of a target anatomical structure that may be below other portions of the anatomical structure. The parallax display may allow an operator to view soft tissue that is located below hard tissue.

[0029] In an eighth aspect of the present disclosure, a method for medical imaging using an imager is provided. The method according to this aspect may include the following steps: placing an imager adjacent to an anatomical part, generating an image data set based on signals transmitted and received by each transducer array, and generating a volume image data set by combining the image data set. The imager may include multiple transducer arrays. Multiple transducer arrays may define an area defined by a length and a width. The anatomical part may include hard tissue and soft tissue. The hard tissue may be located between the imager and the soft tissue. The hard tissue may include one or more gaps. The processor may select each transducer array to generate and receive signals. The volume image data set may be defined by a volume defined by an area and a depth, so that the hard tissue and the soft tissue may be included in the volume image data set. The processor may combine each image data set with the position information of the corresponding each transducer array to generate a volume image data set. The signal transmitted by each of the transducers directly above the hard tissue may propagate through the gap and diverge to contact the soft tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] A more complete understanding of the subject matter of the present invention and various advantages thereof may be realized by referring to the following detailed description, with reference to the following drawings:

[0031] Figure 1A-1I Various views of one embodiment of the apparatus of the present disclosure are shown.

[0032] Figure 2A-2E Various views of another embodiment of the device of the present disclosure are shown.

[0033] Figure 3A-3B Various views of yet another embodiment of the device of the present disclosure are shown.

[0034] Figure 4A-4G Various embodiments of the apparatus of the present disclosure are shown.

[0035] Figure 4H-Figure 4I Representative and exemplary placement of the disclosed apparatus on a patient is shown.

[0036] Figure 5A-5D Representative movement of a housing of one embodiment of the present disclosure is shown.

[0037] Figure 6A-6B Various embodiments of the apparatus of the present disclosure are shown.

[0038] Figure 7A-7B Various embodiments of the apparatus of the present disclosure are shown.

[0039] Figure 8A-8E Various embodiments of tourniquets of the present disclosure are shown.

[0040] Figure 9A-9D Another embodiment of the apparatus of the present disclosure is shown.

[0041] Figure 9E-Figure 9I Another embodiment of a device of the present disclosure and a representative display image are shown.

[0042] Figures 10A-13B Various embodiments of the display (GUI) of the present disclosure are shown.

[0043] Figure 14-15 Various embodiments of the display of the present disclosure are shown.

[0044] Figures 16A-17B Various embodiments of the needle actuation system of the present disclosure are shown.

[0045] Fig.18 and Fig.19 Various embodiments of patches of the present disclosure are shown.

[0046] Fig. 20A and 20BOne embodiment of a skirt of the present disclosure is shown.

[0047] Fig.21A and Fig. 21B Another embodiment of the device of the present disclosure is shown in perspective view and exploded view, respectively.

[0048] Fig. 22 Another embodiment of the apparatus of the present disclosure is shown.

[0049] Figure 23A-23C Various embodiments of the belt of the present disclosure are shown.

[0050] Figure 24A-24C Another embodiment of a belt of the present disclosure is shown.

[0051] Fig.25A - Figure 25I shows various embodiments of the belt of the present disclosure.

[0052] Fig.26A and Fig.26B An embodiment of an attachment device of the present disclosure is shown.

[0053] Fig. 27 Another embodiment of the apparatus of the present disclosure is shown.

[0054] Figure 28-Figure 31C Various embodiments of the inserter assembly of the present disclosure are shown.

[0055] Fig.32 is a schematic perspective view of a visualization device according to one embodiment of the present disclosure.

[0056] Fig.33 It is placed on the target body area Fig.32 Schematic perspective view of the visualization device.

[0057] Fig.34A yes Fig.32 A plan view display of a visualization device.

[0058] Fig.34B yes Fig.32 A first depth view display of a visualization device.

[0059] Fig.34C yes Fig.32 A second depth view display of the visualization device.

[0060] Fig.35A It is placed on the target body area Fig.32 Side view of the visualization device.

[0061] Fig.35B It is placed on the target body area Fig.35AFront view of the visualization device.

[0062] Fig.36A is a schematic perspective view of a visualization device according to another embodiment of the present disclosure.

[0063] Fig.36B is from Fig.36A A schematic perspective view of a display with the frame of the visualization device disassembled.

[0064] Fig.37 is a schematic perspective view of a visualization device according to yet another embodiment of the present disclosure.

[0065] Fig.38A is a schematic perspective view of a visualization device according to yet another embodiment of the present disclosure, viewed from a first perspective.

[0066] Fig.38B Viewed from a second perspective Fig.38B Schematic perspective view of the visualization device.

[0067] Fig.38C is a schematic front view of a visualization device 100 for displaying a parallax view according to another embodiment of the present disclosure.

[0068] Fig.38D yes Fig.38C Schematic perspective view of the visualization device.

[0069] Figure 38E-Figure 38G yes Fig.38C Schematic top view of the visualization device.

[0070] Fig.39 is a schematic perspective view of a visualization device according to yet another embodiment of the present disclosure.

[0071] Fig.40 is a schematic perspective view of a transducer array according to one embodiment of the present disclosure.

[0072] Figure 41A-41C It shows freedom Fig.40 Schematic perspective view of the three-dimensional visualization of the two-dimensional image generated by the transducer array.

[0073] Fig.42 is a schematic perspective view of a transducer array according to another embodiment of the present disclosure.

[0074] Fig.43 is a schematic perspective view of a transducer array according to another embodiment of the present disclosure.

[0075] Fig.44 is a front view of a transducer array according to yet another embodiment of the present disclosure.

[0076] Fig.45 is a front view of a transducer array according to yet another embodiment of the present disclosure.

[0077] Fig.46 is a schematic perspective view of a transducer array according to another embodiment of the present disclosure.

[0078] Fig.47 is a front view of a transducer array according to another embodiment of the present disclosure.

[0079] Fig.48 is a schematic perspective view of a transducer array according to yet another embodiment of the present disclosure.

[0080] Fig.49 is a schematic perspective view of a transducer array according to yet another embodiment of the present disclosure.

[0081] Fig.50 is a side view of a transducer array according to another embodiment of the present disclosure.

[0082] Fig.51 is a schematic perspective view of a transducer array according to yet another embodiment of the present disclosure.

[0083] Fig.52 is a schematic perspective view of a transducer array according to yet another embodiment of the present disclosure.

[0084] Fig.53 is a flow chart illustrating steps for performing a surgical procedure using a visualization device according to one embodiment of the present disclosure.

[0085] Fig.54 is a flow chart illustrating steps for performing a surgical procedure using a visualization device according to another embodiment of the present disclosure.

[0086] Fig.55 yes Figures 38C-38G Schematic perspective view of the visualization device.

[0087] Figure 56A-Figure 56C yes Fig.32 A schematic top view of a visualization device showing a graphical user interface display according to an embodiment of the present disclosure.

[0088] Figure 57A-Figure 57C yes Fig.32 A schematic top view of a visualization device is shown, which shows a graphical user interface display according to another embodiment of the present disclosure.

[0089] Figure 58A-Figure 58C yes Fig.32A schematic top view of a visualization device is shown, which shows a graphical user interface display according to another embodiment of the present disclosure.

[0090] Fig.59 yes Fig.32 A schematic perspective view of a visualization device of FIG. 1 is shown, which shows a graphical user interface display according to another embodiment of the present disclosure.

[0091] Figure 60A-60C yes Fig.32 A schematic top view of a visualization device is shown, which shows a graphical user interface display according to another embodiment of the present disclosure.

[0092] Fig.61A Fig.61C yes Fig.32 A schematic top view of a visualization device is shown, which shows a graphical user interface display according to another embodiment of the present disclosure.

[0093] Fig.62 yes Fig.32 A schematic perspective view of a visualization device of FIG. 1 is shown, which shows a graphical user interface display according to another embodiment of the present disclosure.

[0094] Figure 63A-Figure 63D yes Fig.32 A schematic top view of a visualization device showing a graphical user interface display according to an embodiment of the present disclosure.

[0095] Fig.64A and Fig.64B yes Fig.32 A schematic top view of a visualization device showing a graphical user interface display according to an embodiment of the present disclosure.

[0096] Figure 65A-Figure 65E An embodiment of a method of using the device of the present disclosure is shown.

[0097] Figure 66A-Figure 66E Various locations are shown in which the apparatus of the present disclosure may be used.

[0098] Figure 67A-Figure 67C An embodiment of the device of the present disclosure is shown.

[0099] Figure 68A-Figure 68D Another embodiment of the apparatus of the present disclosure is shown.

[0100] Figure 69A-Figure 69C Another embodiment of the apparatus of the present disclosure is shown.

[0101] Figure 70A-70C Another embodiment of the apparatus of the present disclosure is shown.

[0102] Figure 71A-Figure 71D Another embodiment of the apparatus of the present disclosure is shown.

[0103] Fig.72A and Fig.72B Another embodiment of the apparatus of the present disclosure is shown.

[0104] Fig.73A and Fig.73B Another embodiment of the apparatus of the present disclosure is shown.

[0105] Figure 74A-Figure 74C Another embodiment of the apparatus of the present disclosure is shown.

[0106] Figure 75A-Figure 74C Another embodiment of the apparatus of the present disclosure is shown.

[0107] Fig.76A and Fig.76B Another embodiment of the apparatus of the present disclosure is shown.

[0108] Figure 77A-Figure 77C Another embodiment of the apparatus of the present disclosure is shown.

[0109] Figure 78A-78C Another embodiment of the apparatus of the present disclosure is shown.

[0110] Figure 79A-79H Various embodiments of the object features of the present disclosure are shown.

[0111] Figure 80A-80C An embodiment of a gasket of the present disclosure is shown.

[0112] Figure 81A-Figure 81C Another embodiment of a gasket of the present disclosure is shown.

[0113] Figure 82A-D Another embodiment of a gasket of the present disclosure is shown.

[0114] Figure 83A-Figure 83I Shows Figure 81A-Figure 81C Various embodiments of the pads are shown in .

[0115] Fig.84 A pad according to another embodiment of the present disclosure is shown.

[0116] Figure 85A-Figure 85C A needle insertion operation according to various embodiments of the present disclosure is shown.

[0117] Fig.86A A device having an inserter assembly according to an embodiment of the present disclosure is shown.

[0118] Fig.86B Shows Fig.86AA top view of an inserter assembly of a device.

[0119] Fig.87 Shows Fig.86B A cross-sectional view of an inserter assembly.

[0120] Fig.88 Shows Fig.86B Another cross-sectional view of the inert component.

[0121] Figure 89A-Figure 89C Shows Fig.86B The needle driver of the inserter assembly.

[0122] Fig.90 A front view of an inserter assembly according to another embodiment of the present disclosure is shown.

[0123] Fig.91 Shows Fig.90 A top view of the interposer assembly.

[0124] Fig.92 Shows Fig.90 A cross-sectional view of an inserter assembly.

[0125] Figure 93A-93F Shows Fig.90 A view of the components of the interposer assembly.

[0126] Fig.94 A front view of an inserter assembly according to another embodiment of the present disclosure is shown.

[0127] Fig.95 Shows Fig.94 A top view of the mechanism of the inserter assembly.

[0128] Fig.96 Shows Fig.94 A side view of the mechanism of the inserter assembly.

[0129] Fig.97 An isometric view of an inserter assembly according to another embodiment of the present disclosure is shown.

[0130] Fig.98 Shows Fig.97 A schematic side view of the mechanism of the inserter assembly.

[0131] Fig.99 Shows Fig.97 A top view of the mechanism of the inserter assembly.

[0132] Fig.100 Shows Fig.97 An isometric view of the mechanism of the inserter assembly.

[0133] Figure 101A-Figure 102B A visualization device according to another embodiment of the present disclosure is shown.

[0134] Fig.103A Shows the use of Fig.101A Methods for visualizing devices.

[0135] Fig.103B and Fig.103C Shows Fig.101A Support accessories for visualization equipment.

[0136] Figure 104A-104D A transducer and a pad according to another embodiment of the present disclosure are shown.

[0137] Fig.105 A brace according to another embodiment of the present disclosure is shown.

[0138] Fig.106 Another embodiment of the present disclosure is shown coupled to Fig.105 Visualization device on the brace.

[0139] Figure 107A-107E A visualization system according to another embodiment of the present disclosure is shown.

[0140] Figure 108A-108C A kit according to another embodiment of the present disclosure is shown.

[0141] Figure 108D-108G Shows Fig.108A The kit is suitable for various applications.

[0142] Figure 108H A table showing visualization device specifications according to another embodiment of the present disclosure is shown.

[0143] Fig.109 A custom pad is shown according to another embodiment of the present disclosure. Fig.108A Another application of the suite.

[0144] Figures 110A-110D A visualization system according to another embodiment of the present disclosure is shown.

[0145] Fig.111A and Fig.111B A pad according to an embodiment of the present disclosure is shown.

[0146] Fig.112A and Fig.112B A pad according to another embodiment of the present disclosure is shown.

[0147] Fig.113 A pad according to another embodiment of the present disclosure is shown.

[0148] Fig.114A A pad according to another embodiment of the present disclosure is shown.

[0149] Fig.114B and Fig.114C Shown in the absence of Fig.114A The liner is in the case of intravenous insertion.

[0150] Figure 115A-115C A pad according to another embodiment of the present disclosure is shown.

[0151] Fig.116 A visualization system according to another embodiment of the present disclosure is shown.

[0152] Fig.117 A visualization system according to another embodiment of the present disclosure is shown.

[0153] Fig.118A and Fig.118B An inserter assembly according to another embodiment of the present disclosure is shown.

[0154] Fig.119A and Fig.119B A visualization system according to another embodiment of the present disclosure is shown.

[0155] Fig.120A – Fig.120D A vein dilator according to an embodiment of the present disclosure is shown.

[0156] Fig.121 An inserter assembly according to another embodiment of the present disclosure is shown.

[0157] Figure 122A-122D A visualization device according to another embodiment of the present disclosure is shown.

[0158] Fig.123 A visualization device according to another embodiment of the present disclosure is shown.

[0159] Fig.124 A sterile adhesive according to another embodiment of the present disclosure is shown.

[0160] Fig.125A and Fig.125B A needle according to an embodiment of the present disclosure is shown.

[0161] Fig.126 An inserter assembly according to another embodiment of the present invention is shown.

[0162] Figure 127A-127D A visualization component according to another embodiment of the present disclosure is shown.

[0163] Fig.128A and Fig.128B A visualization component according to another embodiment of the present disclosure is shown. DETAILED DESCRIPTION

[0164] As used herein, the terms "needle" and "cannula" will be used interchangeably and as such, unless otherwise specified, the explicit use of either term includes the other term. And typically, the cannula will be positioned into the patient's body by using a needle, whereby the needle is first inserted and the cannula is slid over the needle into the patient's body, at which point the needle is removed, leaving the cannula. The interchangeable terms needle and cannula also include similar devices such as microcannulas, their sharp and blunt variations, their hard or flexible variations, and other tubular structures. Similarly, the term "circulatory system" means any blood vessel, vein, artery, microvasculature, etc. The term "puncture site" means a location on the patient's body through which an operator typically penetrates the skin to position at least a portion of a needle or cannula into the patient's body. Although the devices, techniques, systems, kits, and methods of the present disclosure generally refer to inserting a needle or cannula into the circulatory system, or the devices, techniques, systems, kits, and methods of the present disclosure provide examples of inserting a needle or cannula into the circulatory system, the present disclosure also contemplates positioning a needle or cannula in other anatomical locations, such as "transosseous" techniques in which at least a portion of the needle is positioned within a patient's bone (e.g., within the intramedullary canal).

[0165] As used herein, "semi-autonomous" means that the device can perform functions with some degree of operator (e.g., nurse, technician, doctor, etc.) interaction. For example, a "semi-autonomous" feature may require an operator to assist in navigating the device to a general area of ​​the intended puncture site by viewing a user interface and manipulating the device, and the device itself can further navigate to the precise puncture site location once in the general area. Semi-autonomous may additionally include, for example, a degree of positioning in which the operator clamps or controls a cannula or connecting structure to perform some or all of the motion under image guidance, and has a partial robotic positioning assistance-such as the supplement of robotic auto-correction capabilities. On the other hand, an "autonomous" or "fully autonomous" feature will be able to fully perform a specific function without or with minimal need for operator interaction, or with minimal need for operator interaction. For example, once the puncture site has been located, the operator can confirm that the location is correct by pressing a button, an actuator, a display screen gesture, etc., and this action activates the device to manipulate the needle to the puncture site and insert the needle into the puncture site and the circulatory system, all without any interaction from the operator. The terms "semi-autonomous" and "autonomous" may be used to describe a device generally, to describe a specific functionality, or to describe any group of functionality.

[0166] An "operator" or "user" as defined above and used throughout the text may be a single individual or more than one individual, as appropriate. For example, while it is possible for a single user to perform all of the steps for a particular use of one of the devices herein, it may also be possible for more than one user to be involved, such that each user performs some but not all of the steps. Further to this example, a first user (e.g., a layperson, an assistant, a first responder, a member of the public, etc.) may perform the less skilled steps of attaching the device to a patient, while a skilled person (e.g., a technician, a doctor, a nurse, etc.) performs the subsequent steps of positioning the needle and inserting the needle, and so on.

[0167] As used herein, the terms "gel pad", "patch" and "pad" will be used interchangeably and as such, unless otherwise stated, the explicit use of any of these terms includes the other terms. As used herein, the terms "needle actuation system", "inserter assembly" and "cannula module" will be used interchangeably, and likewise, unless otherwise stated, the explicit use of any of these terms includes the other terms. As used herein, the terms "sensor array", "(one or more) sensors" and "transducer" will be used interchangeably and as such, unless otherwise stated, the explicit use of any of these terms includes the other terms.

[0168] The present invention can be used to visualize any desired anatomical structure and / or medical device or instrument, and further can be used alone as a visualization tool (e.g., for diagnosis, viewing healing after trauma or surgery, etc.) or in combination with any desired medical device or instrument. Similarly, the present invention is contemplated to be used for any desired anatomical structure. However, for ease of review and explanation, most of the examples discussed herein will focus on use with a needle for piercing the skin and / or entering the patient's vascular system. Although such embodiments are only exemplary, they do provide an explanation of the benefits associated with the present invention. In addition, the present invention can be used as an independent imaging system for any imaging procedure (such as abdominal, venous, pelvic, transabdominal, transvaginal, transrectal, obstetric, carotid and abdominal aorta imaging).

[0169] 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, most of the examples described herein will focus on the use of CMUT sensors.

[0170] Usually equipment

[0171] The devices of the present disclosure are generally suitable for semi-autonomous or fully autonomous positioning of a needle or cannula into a patient's body. Such devices may include various features to provide semi-autonomous or fully autonomous functions, such as coarse and / or fine positioning, mapping and tracking elements, needle control and positioning elements, cleaning sterilization and puncture site preparation elements, pain management elements, patient distraction elements, and / or the like.

[0172] The device of the present disclosure can be placed on the skin of the patient to produce an image on the other side of the side in contact with the skin. Therefore, in some embodiments, these devices are configured to be light, thin and / or have the ability to generate images with sufficient resolution and / or maintain real-time scanning control for various programs. CMUT, PMUT or other suitable transducers can be used to capture images in real time. In some embodiments, the combination of CMUT and PMUT can be used to optimize the device for a specific application. For example, the 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 power consumption of the device. In addition to the transducer, these devices can include mixed signal electronics on an integrated circuit, which can be combined with the transducer. The device can receive data from a sensing integrated circuit and engage 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 required by the integrated circuit to determine the beam angle, frequency and many other parameters.

[0173] like Figure 1A-1I As shown, in one embodiment of such a device, the device 10 of the present disclosure generally includes three components: a housing 100, a base 200, and an inserter assembly 300. The housing 100 includes various elements that provide functionality to the device, such as positioning, mapping and tracking elements, needle control and positioning elements, pain management capabilities, patient distraction capabilities, etc. Therefore, the housing 100 must be of a size sufficient to accommodate all of these elements. For example, a device used in a hospital to perform multiple daily needle insertions and requiring the ability to couple with multiple needles and other accessories may require a relatively large housing, however, a device that is configured to be portable and designed for specific applications without the need to couple with various needles and other accessories may have a more compact housing.

[0174] Base 200 provides positioning and fixing of the skin surface of the device adjacent to the patient. As shown, the base may include an outer frame 202, which defines an internal volume and has a hole 204 passing through at least one surface of the frame 202. Base 200 can be mounted on the skin surface of the patient and fixed to the skin surface of the patient by at least one band attached to the base. Hole 204 provides window 206, and inserter assembly 300 including a needle and / or cannula can be positioned through window 206. In addition, hole 204 allows for navigation assistance (as described below) and / or for other elements of housing 100 to interact with the patient.

[0175] The housing 100 may also include attachment features to allow the housing to be easily attached to and removed from the base 200. For example, at least a portion of the housing 100 may be positioned within the interior volume of the base 200 and held in place by friction fit, magnetic attraction, snap fit, etc. Such positioning may allow the housing 100 to be close to the window 206, which may provide improved functionality of various elements in the housing, as discussed in more detail below. In alternative arrangements, the housing 100 and the base 200 may be an integrated structure, or may also be a monolithic structure, rather than a separate connectable structure.

[0176] The insert assembly 300 may be packaged or contained in a manner that allows for simplified engagement with the housing 100. As shown, the housing 100 may include a recess 101 ( Figure 1C and Figure 1H-1I ) to provide clearance for insert assembly 300 after device 10 is assembled, but other ways of configuring the various elements to fit together are also contemplated. Insert assembly 300 may include features that facilitate improved fit, improved stability, improved functionality within device 10, such as fins 301 ( Figure 1E ) can lie flat against the base 200 on either side of the hole 204, maintaining the relative positioning of the base 200, component 300 and optional protective mask 700 prior to use, and providing a stable contact base for the component 300 against the patient's skin during use.

[0177] In addition to the needle and / or cannula, the inserter assembly 300 may also include a fixture and valve, a section of tubing, a filter, a catheter body returning to the Luer lock, any combination of these, etc. In this way, the insertion assembly 300 may include (as known in the art) an entire intravenous injection system or any part of an intravenous injection system, but the inserter assembly will typically include at least a needle and / or cannula to start the intravenous injection installation process. Alternatively, the inserter assembly 300 may only include a needle, or a needle and a vial, for less complex operations (such as for collecting blood samples from patients). Additional examples of the inserter assembly are discussed below. In the above-mentioned alternative arrangements of an integrated structure or a monolithic structure, the insertion assembly 300 may similarly be a part of an integrated structure or a monolithic structure.

[0178] The device 10 may further include a protective mask 700, which may be positioned on the underside of the base 200, such as Figure 1A As shown, the protective mask 700 is positioned between the base 200 and the skin surface of the patient. Before use and / or before the housing 100 is connected to the base 200, the mask 700 can be used to keep the inserter assembly 300 in the hole 204. In addition, the mask 700 can have other features so that it can perform other functions. For example, the mask 700 can provide a non-sterile surface for use when locating the puncture site, so that once the puncture site is determined, the non-sterile surface can be removed to expose the surface of the sterile base 200 for positioning at the puncture site. Alternatively, for example, the mask 700 can include a sterilizing composition located thereon to sterilize the skin surface during the positioning process of locating the puncture site. Further, for example, if included on the device, the mask can include optical properties so that it can assist in scanning and visualization of the puncture site, and / or the mask can include a saline hydrogel layer for use with ultrasound.

[0179] Figure 2A-E shows a device 20 according to another embodiment of the present disclosure. Device 20 is similar to device 10 in some respects, and device 20 includes a housing 400 that can be docked on a base 500. Base 500 may include patient engagement features (such as, at least one band 508 as shown) to mount and fix the device on the patient's skin surface. In addition, base 500 is constructed to be thinner than base 200 of Figure 1, so housing 400 can be engaged with base 500 in any desired manner (such as by magnetic interaction, snap fit, press fit, etc.). In addition, since base 500 is a thinner construction, housing 400 does not need to be positioned within the volume of the base because hole 504 and inserter assembly 600 are close to the upper edge of base 500. Device 20 can perform a series of functions based on elements arranged in housing 400 or elements attached to housing 400, and device 20 may include other features such as patches as described above.

[0180] The device 20 includes Figure 2C Hole 504 shown in the figure, and plate 550 is positioned therein before use.As shown in the figure, plate 550 includes a holder 552, and holder 552 can clamp inserter assembly 600 in a position relative to base 500, until housing 400 is coupled to the base, at which point housing 400 will also engage with inserter assembly 600, so that plate 550 is unnecessary.Like this, plate 550 is particularly useful for the base 500 that the relative position of inserter assembly 600 is maintained in its packaging, and is particularly useful before use.For example, once the base is removed from its packaging, plate 500 can remain in position, and the base is positioned on the patient at or near the puncture site.Alternately, for example, once the base is removed from its packaging, the base can be coupled to housing 400, so that plate 550 is removed before the base is positioned on the skin surface.Hole 504 can have any desired size, and as shown in the figure, hole 504 is quite large to allow base and various elements therein to freely enter the skin surface.

[0181] FIG. 3A to FIG. 3B Another embodiment of the present disclosure is shown. As shown, the device 30 includes a housing 700 and a base 800, wherein, in this embodiment, the base is in the form of a wrap-around brace. Such a base 800 may be particularly useful for locating a puncture site and positioning an inserter assembly (not shown) through the puncture site on a hand or foot. Further to this embodiment, the housing 700 may not be fixed relative to the base 800, but may be movable in at least one degree of motion. As described above, the housing may include various electronic devices to impart functionality to the device. Although Figure 1A-Figure 2EThe device can be moved along the length of the arm, but the base 800 is tied around the specific anatomical structure of the hand or foot. Therefore, while the base may have limited movement available to it, the housing 700 can be moved relative to the base to locate the puncture site and navigate the inserter assembly therethrough, as described below. The base 800 can also include a tourniquet 801 located proximal to the puncture site (i.e., between the puncture site and the heart), as shown, which is physically and / or electronically integrated with the base or separate and independent from the base (such as Figure 4A Tourniquet 1801). As discussed further below, an integrated tourniquet, whether physically, electrically and / or via software, can provide additional functionality to the housing.

[0182] In another embodiment, Figure 4A-Figure 4I Various embodiments of devices are shown that include a base, a housing, and each device may optionally include an integrated tourniquet (although for ease of illustration, only a Figure 4A , Figure 4B , Figure 4H and Fig. 4I Tourniquet is shown). Each of these embodiments may include a separate or modular arrangement including a base separate from the housing, which may be connected to each other during use, or alternatively, the base and the housing may be an integrated structure, or may also be a single-piece structure.

[0183] Figure 4A One such embodiment is shown, wherein the device 130 includes a base 1800 and a housing 1700. As shown, the base 1800 is elongated in shape, with a generally rectangular hole 1804 that receives the housing 1700, which is also generally rectangular in shape. The base 1800 is shown as having two bands 1808a, 1808b, but may include any number of bands, or indeed any other fixing features to fix the base to the patient. The housing 1700 may also include an inserter assembly 1900 thereon. Optionally, the device 130 may also include a tourniquet 1801 that may be connected to the base 1800 and / or the housing 1700 via a connector 1802. As shown, the connector 1802 may be rigid so that the distance between the tourniquet and the base remains constant, which may create a more stable structure once positioned on the patient. Alternatively, as discussed in more detail below, connector 1802 may be flexible, or may even be simply a wire connection between the tourniquet and the housing (eg, for communications, power, etc.).

[0184] The device 130 can provide a simplified setup because the housing 1700 and the aperture 1804 allow relative movement between the base 1800 and the housing 1700, so that the base 1800 (and optionally the tourniquet 1801) can be fixed to the patient so that the aperture 1804 coincides with the general location of the intended puncture site (e.g., on the patient's upper forearm). With the base 1800 fixed, the user can navigate the housing 1700 along the patient's skin and / or over the patient's skin within the aperture 1804 until the desired puncture site is located and aligned with the inserter assembly 1900. As shown, the housing 1700 can be moved in any direction within the aperture 1804, i.e., in any of the x-direction (i.e., side to side), the y-direction (i.e., along the length, or toward / away from the tourniquet), and / or the z-direction (i.e., toward / away from the patient's skin).

[0185] Figure 4B-Figure 4E Various alternative embodiments of the device 130 are shown. Specifically, although Figure 4B-4D Each of the devices includes a housing and body similar to device 130, but with a different band associated with the body. Figure 4B The device includes a single offset strap that can be adapted to be attached to a patient's hand or foot. That is, the strap is positioned proximally relative to the housing (and inserter assembly) so that the strap can be positioned over a more stable, wider portion of the hand or foot, while the inserter assembly will be better positioned to align with the desired puncture site. On the other hand, Figure 4C Includes a strap that is generally centered and aligned with the body and housing. While this variation may still be suitable for positioning on a hand or foot, this variation may also be better suited for positioning elsewhere, such as on a forearm. Similarly, Figure 4D The device includes a wider strap and may therefore be better suited for positioning on the forearm or even larger anatomical structures such as the upper arm or leg. Figure 4A Similar to the dual strap variation of the present invention, the wider strap can provide increased fixation and stability to the device. The strap can be formed of any material desired and suitable for use with a medical device that contacts the patient's skin, and can further include a coating if desired. For example, the strap can be formed of or include a conductive material (such as a hydrogel), which can assist in navigation and other functions associated with the housing 1700.

[0186] Figure 4E A variation of the base 1800 is shown in which the base may not completely surround the housing. Instead, the base may be incomplete, such that the hole 1809 in the base is open. The base being complete or incomplete may result in any desired shape.

[0187] Figure 4FYet another embodiment of the device 130' is provided, where the base 1800' alternatively includes curved ends, rather than a generally rectangular shape, thereby having a curved rectangle at the opposing ends. The housing 1700' has a shape similar to the aperture 1804'. A band 1808' may also be included, and the band 1808 may have any desired shape. In this embodiment, the width of the aperture 1804' and the width of the housing 1700' may be similar or nearly similar, such that the housing 1700' may move in the y-direction (e.g., along the length of the aperture 1804' and toward either of the curved ends), but has limited or zero movement in the x-direction (e.g., side to side). For example, such an embodiment may be useful in situations where longitudinal translation imaging or navigation features of the housing 1700' are desired, as well as limiting most, if not all, side-to-side movement of the housing 1700'. Alternatively, the band may also include a band hole that allows the housing to slide in a side-to-side (x-direction) direction (as described below with respect to Fig. 6A discussed).

[0188] Figure 4G-Figure 4I Yet another alternative embodiment of a device 230 is shown that is similar in some respects to device 130 in that device 230 includes a base 2800 and a housing 2700, but in this embodiment, both the base and the housing are generally circular, and the base 2800 includes an aperture 2804, which is also generally circular, and a single band 2808. As in other embodiments described above, device 230 may also include a tourniquet 2801, which may be an integrated aspect of device 230. However, Figure 4G-Figure 4I Another variation of a tourniquet that can be used with any of the embodiments disclosed herein is shown, whereby in this variation, the tourniquet 2801 can be electrically connected to the housing 2700 via a wired connection 2802, although the connection can be via Bluetooth or other wireless capabilities (e.g., such as Figure 8D-Figure 8E Alternatively, the tourniquet can be completely independent of the device 230 both physically and communicatively. Further, Figure 4H-Figure 4I Various potential anatomical locations of the devices disclosed herein are shown, whereby the device 230 is shown positioned on the hand, on the forearm, on the upper arm, or on the neck. In addition, in the case of using a tourniquet, such as in the case where the device 230 is located on the hand, the tourniquet 2801 is positioned proximal to the housing 2700 and the injection assembly 2900 to manage blood flow to the puncture site.

[0189] Figure 5A-5D Shows Figure 4G Representative directions of movement of housing 2700 of device 230 . Figure 5A A device 230 is shown with an integrated tourniquet 2801 communicating via a wired connection 2802. For example, Figure 5B 2800 so that the inserter assembly rotates along arc R. As described above, this rotational capability, along with the ability to move the housing 2700 in the x, y, and z directions within the aperture 2804, allows for an infinite number of possible positions of the inserter assembly 2900 within the aperture 2804, thereby allowing for an infinite number of possible positions of the inserter assembly 2900 within the aperture 2804. Figure 5C-5D Two such locations are shown in FIG.

[0190] In another embodiment, Figure 6A-6B Another embodiment of a device 130" is shown, which is similar to Figure 4F , but the aforementioned x-direction movement (e.g., side-to-side) is substantially eliminated, so that the housing 1700" can only translate in the y-direction within the hole 1804". In addition, the device 130" includes a belt hole 1809" within the belt 1808", and a portion of the base 1800" (or housing 1700" or other structure) can travel within the belt hole 1809", thereby providing an additional direction of movement for the housing 1700". Thus, as Figure 6B As shown in FIG. 1 , housing 1700″ can travel in each of the x-direction (i.e., X translation), the y-direction (i.e., Y translation), and rotationally along an arc (i.e., rotation). Very similar to Figure 5A-5D The ability of housing 2700" to move in each of these directions provides an infinite number of possible positions of housing 1700" (and inserter assembly, if present) relative to the patient.

[0191] Figure 7A-7B Still another embodiment of a device 330, 330' is shown that includes a monolithic body and housing 3800, 3800' and an inserter assembly 3900, 3900' that is movable relative to the body / housing 3800, 3800'. Fig. 7A , the assembly 3900 may be movable relative to the body / housing 3800 via one or more micro-motion mechanisms 3950 to allow for fine movement of the assembly 3900 relative to the patient's anatomy. Figure 7B The assembly 3900' shown in FIG. 1 can be connected to the body / housing 3800' via a ball joint mechanism 3950', which can similarly provide movement of the assembly 3900. Either mechanism 3950, 3950' can allow the assembly 3900, 3900' to move in any (as defined below) "XYZRTD" direction, and can provide such movement in small increments.

[0192] Although Figure 1A-Figure 6B Various devices provide relatively large amounts of movement, but Figure 7A-7BThe devices 330, 330' are directed to relatively small amounts of movement. Therefore, these devices can be used in different ways. For example, once the puncture site has been determined (whether by using the main body / shell 3800, 3800' or by another device), the devices 330, 330' will be positioned, so the device 330 will not be fixed to the patient until the puncture site is accurately determined. Alternatively, the other devices described above can be positioned in a general area of ​​the desired puncture site, and then such a device is fixed to the patient, and then the shell and / or inserter assembly can be moved to find the desired puncture site. Of course, any device discussed herein can include a combination of these motion features, so that, for example, the device can have both relatively large and relatively small movements (that is, relatively large movements can be used to locate the puncture site, and then relatively small movements can be used to navigate the needle tip to the puncture site and pass through the puncture site).

[0193] Back to the optional tourniquet, Figure 8A-8C Various positions of an optional tourniquet 2801 relative to the device (i.e., the housing / body) are shown. While the variations shown are possible positions, any other positions of the tourniquet relative to the housing / body of the device are contemplated. Likewise, such as Figure 8D-Figure 8E The illustrated wireless 2801 ′ (or otherwise not physically connected) tourniquet 2801 may also be positioned at any distance relative to the housing / body 230 as desired.

[0194] Now refer to Fig.105 , which shows a brace 24000 according to another embodiment of the present disclosure. The brace 24000 includes a tourniquet 24004 having an integrated strap to adjust the tension of the tourniquet. A window 24006 is provided for receiving a pad 24002. Various devices including visualization devices and inserter assemblies can be attached to the window 24006.

[0195] Various other types of bands may also be used with any of the devices described above, some of which are more fully disclosed and described below. In addition, instead of just a single base and a single housing, the device of the present disclosure may include multiple housings, each capable of performing a separate function or a portion of a desired function.

[0196] Fig.21A and Fig. 21B FIG. 4 shows a device 40 according to another embodiment of the present disclosure. Fig.21A As best shown, device 40 is generally similar to device 20, but includes a band 508' extending through outer frame 502'. This arrangement allows a pre-injected patch 700' to be placed on band 508' ( Fig. 21B) or under the band 508' (not shown). When the band 508' is placed on the pre-injection patch, the band 508' can be used to fix the injection pre-injection patch 700'.

[0197] Now refer to Fig. 22 , which shows a device 50 according to another embodiment of the present disclosure. Device 50 is generally similar to device 50, but includes multiple modules engaged with an external frame 502'. A vein preparation module 500A is attached to the external frame 502', which is attached to the patient by a band 508'. The vein preparation module 500A helps to determine the vein relative to the (usually less compressible) artery. The vein preparation module 500A can additionally vibrate or implement a tapping motion to stimulate the blood vessel so that it is more optimized, more expanded and / or raised closer to the skin surface for more cannulation conditions - that is, so as to increase the size of the lumen and become an easier target. The vein preparation module 500A can then be replaced with an imager module 500B to survey the vascular system and identify the ideal injection site. Finally, the cannulation module 500C can be coupled to the external frame 502' to place the needle into the prepared and predetermined vein position. Although a device with three modules for needle insertion operations is described here, other embodiments can have two, four or more modules specifically configured for other operations.

[0198] Figure 23A-23C Various lashing configurations are shown according to another embodiment of the present disclosure. Fig.23A A strip 608 is shown that may be applied underneath the base 100. Fig. 23B As shown, the strap 708 extends through the base 100. Fig.23C As shown, strap 808 can be placed on top of base 100. The desired strapping configuration can be selected based on the desired fixation for attaching the device to the patient.

[0199] In another embodiment, there is provided Figure 24A-24C . The automatic tightening band 1008 is configured to automatically tighten around the appendage as indicated by directional arrow 1009 to secure the device. The automatic tightening band 1008 can be calibrated to tighten to a desired tension to provide precise tension during operation. When the automatic tightening band is a self-tightening strip, no action from the operator is required to secure the device to the appendage. Fig.24C Best seen, the self-tightening strap 1008 allows the device to be automatically adjusted along the fixed axis 1110 to find the ideal position of the device.

[0200] Now refer to Fig.25A - Figure 25I showing various embodiments of the belt of the present disclosure. Fig.25AThe belt 508A shown in the figure can be worn by the patient, allowing the operator to attach the housing 100 before the needle is inserted. When the needle insertion or other operation is completed, the housing 100 can be easily detached from the belt 508A, leaving the belt 508A at the surgical site. If necessary, the attachment belt 508A can be reused to enter the same surgical site.

[0201] Fig.25B The band 508B shown in FIG. 5 includes one or more self-tightening tourniquets 509B. The self-tightening tourniquets 509B can automatically tighten around the vein to block venous blood flow during needle insertion.

[0202] Fig.25C A strap 508C is shown according to another embodiment of the present disclosure. The strap 508C is configured as a sleeve that can be attached to an appendage of the patient, such as an arm or leg. The housing 100 can be attached to the strap 508C via an opening 509C or a side slot 510C on the sleeve. The strap 508C can be made of polyester, spandex, etc. to form a low-profile sleeve that can be integrated with the patient's body.

[0203] Fig.25D 508D according to another embodiment of the present disclosure is shown. The strap 508D is configured to secure a housing 100D having a slot 509D for receiving the strap. Fig.25D As shown, the strap 508D can be slid onto the slot 509D on the housing 100D to secure the housing 100D to the strap.

[0204] Fig.25E A strap 508E is shown 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 hang freely on either side of the appendage. Thus, the housing 100 can be securely attached to the surgical site by utilizing only the gravity action of the weight 509E.

[0205] See now Fig.25F , which shows a band 508F according to another embodiment of the present disclosure. Band 508F is configured as a foldable body having wings that surround housing 100 when the device is not in use. Fig.25F As shown, the strap 508F can be conveniently opened to extend laterally from the housing 100 to attach the device to the patient. Adhesive or other fixing means can be added to the strap 508F to enhance the attachment of the strap to the patient.

[0206] Fig.25F- FIG. 25I shows a band 508G according to another embodiment of the present disclosure. Band 508G includes one or more tourniquets 509G, which can be opened ( FIG. 25H ) and closed ( FIG. 25I ) by a clamp 510G. Once the desired surgical position is identified by housing 100, as shown in FIG. 25I , clamp 510G can be locked to secure the device to the target position. Although a clamp is shown in this embodiment, other securing devices such as clasps, brackets, grips, etc. can be used.

[0207] Fig.26A and Fig.26B An embodiment of an attachment device of the present disclosure is shown. Fig.26A The housing 100 is shown with an adhesive layer 702 attached to the distal end. Fig.26A As shown, the operator can peel off the adhesive layer 702 and securely attach the housing 100 to the desired surgical site. Fig.26B A housing 100 is depicted having a suction layer 704 at the distal surface, the suction layer having a plurality of holes 705. A suction generating device (not shown) generates a vacuum to allow the housing 100 to be securely attached to an appendage. By turning off the suction, the housing 100 can be easily disassembled and removed from the surgical site. Attachment devices 702 and 704 allow for safe placement of the device without strapping to an appendage, and therefore these attachment devices can be particularly useful when performing operation of the device on a child.

[0208] Fig. 27 A device 60 according to another embodiment of the present disclosure is shown. The device 60 includes a slot 61 to allow an operator to place his / her fingers in the slot to securely clamp the device on the target surgical site. Thus, the device 60 does not require an attachment device or a fixation device, as the operator can simply use his / her fingers to clamp the device and fix the device 60 during operation.

[0209] Additional and alternative embodiments are also disclosed in the present disclosure. Figure 28-Figure 33 Shown in.

[0210] Equipment structure

[0211] like Figure 1A-Figure 2E As shown, in some embodiments, the device of the present disclosure can be primarily constructed as a single unit. Specifically, the device can be constructed as a single housing containing various functional elements discussed herein. The housing can be separable from the base so that, for example, the base can be first positioned on the patient and then the housing can be positioned on the base. However, in other embodiments, the housing and base can also be a single monolithic unit so that the entire device is positioned on the patient at one time.

[0212] Additionally, regardless of the configuration of the housing and base of the device, the inserter assembly can be separated from the housing and base so that, for example, once the base and housing (whether as a single unit or as separately engageable units) are positioned, the inserter assembly can then be inserted into the device for subsequent use on a patient. Furthermore, providing a needle that can be engaged by the device after the device is already in place can allow for increased functional flexibility because the operator can select a needle of an appropriate size and shape for a selected vessel.

[0213] In one embodiment, the housing is a reusable element. This is useful because the housing will include various electronic devices and other higher cost components. The base may also be reusable, or alternatively, the base may be formed from low-cost polymers, fabrics, paper-based materials, etc. so as to be disposable. Thus, in one example, each patient will use a new base, with a reusable housing being connected to each new base. The reusable housing may also be serializable, and / or the reusable housing may be able to withstand known high-level sterilization methods (such as hydrogen peroxide chambers, vacuum cleaning systems), and / or the reusable housing may be submersible (e.g., IP67 or greater) for immersion or treatment by other washing systems (such as Steris, etc.). The housing may be solid, have zero or near-zero internal air voids, and / or include an airtight seal to prevent the ingress of fluids and / or gases. For example, Figure 1A-1B The base 200 shown in the figure can be disposable, while the housing 100 can be reusable and allows the housing 100 to dock in a new base 200 in each insertion operation. Alternatively, the base 200 can be sterilized and used for a predetermined number of applications and replaced thereafter. The reusable base can also be installed on the mask 700, which can be new at each use, thereby protecting the base from contamination, particularly during the initial positioning and positioning of the desired puncture site. In addition to the mask or replacing the sterile barrier of the mask, it can also be added around the base and removed just before the final positioning. Such a removable sterile barrier can be particularly helpful when the device will navigate a relatively large skin area before selecting the puncture site, so that there is no need to sterilize the large skin area. For example, the sterile barrier can be a flexible plastic film that can slide off, peel off, etc. from the substrate when selecting the puncture site.

[0214] In another embodiment, the needle and base can be packaged together as a kit. Optionally, the mask 700 can be positioned on the base to hold the needle and base together. For example, Figure 1A-1BAs shown, the mask can cover at least a portion of the hole 204, and the mask can include a recess or other engagement feature to hold the needle or inserter assembly 300 in place relative to the hole for simplifying collection of the needle by the housing. Then, once the housing is attached to the base, the needle can then be attached to the housing or otherwise held in place relative to the base and housing. Optionally, the mask can automatically fall off when the base and housing engage—for example, when the housing engages the base and inserter assembly, the inserter assembly can press down into the hole to push the mask away from the base and away from the base.

[0215] The housing may include any elements desired, and as described above, the housing may be reusable and, therefore, will house various electrical and mechanical components. For example, the housing may include a graphical user interface ("GUI") to display dynamic and static images of a 3D scan of the puncture site vein insertion point, servo motors for insertion and retraction of the needle, and the like. The GUI will be included in the semi-autonomous device, while the autonomous device may or may not include the GUI. Alternatively, the autonomous device or semi-autonomous device may include an external GUI rather than a GUI that is part of the housing. As shown throughout, the various device embodiments contemplated herein are small enough to be portable and can be carried by an operator. Although embodiments such as Figure 1A-Figure 4F and Figure 6A-6B Some of the devices shown in FIG. 1 are generally rectangular, but the devices may also be manufactured in other shapes, as described herein, such as Figure 4G-Figure 4I and Figure 5A-5D In addition, the various devices disclosed herein can be manufactured in different sizes and have contoured shapes for specific applications, examples of which are described herein.

[0216] The base portion of the device can be made of a rigid or flexible material. For example, if it is desired that the base is usable at a variety of anatomical locations, the base can include a flexible component that can engage the anatomical structure to configure into a specific geometry. In addition, alternative engagement features can be included in a kit including the base (such as snap-fit ​​features, straps, adhesives, or other similar attachments) to provide flexibility in attaching the device to the patient.

[0217] The device may also be provided as a kit. In one embodiment, the kit includes at least one base, at least one belt, at least one insertion assembly with various needles and component combinations for different applications, at least one protective mask, and at least one or a series of coupling gel pads, etc. A tourniquet may also be included and used in conjunction with the kit, for example to facilitate vein and puncture site location identification 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 use.

[0218] 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 that can be used with the kit. In another embodiment, the kit includes at least one housing and at least one base. At least one inserter assembly may also be included, or at least one or a series of coupling gel pads may be provided separately.

[0219] In any of the above exemplary embodiments of the kit, each component can be packaged separately or together in a single package. For example, a single package can include a housing and then include multiple separately packaged / sterilized bases and / or needles. In addition, if more than one base and / or inserter assembly is in the kit, a single base can be packaged as a sterile combination with a separate inserter assembly. Any of the above kits can also include at least one protective mask, at least one tourniquet, and / or the like.

[0220] The device can be fully or partially assembled depending on the specific application. For example, a fully assembled device can be used by an emergency medical technician in an emergency situation to easily use and establish intravenous access to a patient. A fully assembled device will reduce the number of steps required to perform a needle insertion operation during an emergency. Such a fully assembled, ready-to-use device is useful in emergency rooms, battlefield and field hospitals, ambulances, and the like. Alternatively, a partially assembled device can provide more flexibility and can be used in a wider range of applications by allowing an operator to customize the device for a specific application. Such a partially assembled device may be useful in an operating room, a blood bank, a laboratory, a doctor's office, and the like.

[0221] In one embodiment, the device includes a sensor structure having a wafer-like shape that is integrated with a protective housing that may include (one or more) ergonomic aids and operating controls, such as manual controls, a graphical user interface (GUI, also referred to herein as a display), etc. In addition, other external features may be included that may assist the user during the intubation process by, for example, providing subsurface imaging capabilities, needle or cannula tracking, etc.

[0222] In an exemplary embodiment of the method of use, Figure 65A-Figure 65B As shown, the user grasps the device 4000 and positions it on or above the patient's skin 4002. As described below, the device 4000 includes a sensor or sensor array 4004 to study the patient's subcutaneous anatomy to locate the patient's skin. Fig.65A4008 on the skin surface, thereby entering the skin at the puncture site and ultimately positioning the needle 4006 in the desired blood vessel. Then, as Fig.65B As shown, device 4000 can track needle 4006 as it approaches puncture site 4008. Then, as shown in FIG. Fig.65C and Fig.65D As shown, the user manipulates the needle 4006 to the puncture site and through the skin at the puncture site. Once inside the patient's body, the tip 4010 of the needle is tracked using the device's sensor / sensor array 4004 to observe the needle tip approaching the blood vessel and guide the user to guide the needle tip into the blood vessel, such as Fig.65E Once the needle tip 4010 is positioned in the blood vessel, the vessel is considered cannulated and the user can proceed to perform the desired operation.

[0223] Figure 66A-Figure 66E The device 4000 disclosed herein can be used for a patient's hand ( Fig.66A and Fig.66E ) to arm( Fig.66A ), to the neck( Fig.66B ), to the feet( Fig.66D ) etc. Although these illustrated locations are generally considered to be the primary locations for cannulation of the circulatory system, other locations on the body may also be desirable locations for use of these devices and are also envisioned.

[0224] The following representative physical embodiments and sub-variants of such devices are presented herein. Although certain embodiments may illustrate certain features, components, and / or functions, it should be understood that any of these features, components, or functions may be combined in any of the other representative embodiments in any combination or configuration that is desired or useful.

[0225] Reference Figure 67A-Figure 67C , which shows a substantially flat rectangular device 5000 according to one embodiment of the present disclosure. The bottom surface 5014 is at least partially or completely covered by the imaging sensor 5004. Fig.67B As shown in , the device 5000 is sized to be manipulated by a user's hand. The opposite side is at least partially or completely formed with a viewing screen 5012. The viewing screen can also be a GUI or incorporate a GUI, or have other control capabilities to allow the user to interact with the device.

[0226] Fig.67CShown is a cutaway to expose components of the device 5000 of the present invention. As shown, the device includes a display 5012 on the top surface, 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 instead of a CMUT array.

[0227] The housing 5009 is shaped to accommodate the positioning of the user's hand and may also include a cutout 5011 to provide an improved shape for positioning the needle or cannula 5006 thereon. Specifically, the cutout 5011 may be used to allow the needle or cannula to better approach the anatomical structure being viewed on the display—in other words, the needle may reach closer to the portion of the blood vessel shown on the display.

[0228] In addition, if Fig.67B As shown, the device 5000 may also include the ability to mark 5013 a suggested puncture site 5008 for initial insertion of a needle or cannula into the skin. For example, a laser, camera, focused light (e.g., LED) or mechanical aiming device may be included to help the user locate the optimal puncture site on the patient's skin.

[0229] Optionally, the device may include a pad or other intermediate layer that may be positioned 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 impart sterilization, marking / targeting, or other features to the device. Furthermore, while the device may be reusable, the gel pad may be disposable.

[0230] Now refer to Fig.68A -D, which shows a device 6000 according to another embodiment of the present disclosure. Device 6000 is substantially similar to device 5000, and thus similar elements are referred to by similar numbers within the 6000 series of numbers. The device 6000 of this embodiment includes an extension block having a low profile and a fixed ergonomic aid at one end. The ergonomic aid may be a clip 6014, which also doubles as a pocket clip for user carrying convenience. As shown, the device has a size suitable for carrying in a pocket. Optionally, the device 6000 may also include a charging coil 6017 for wireless charging, or it may include an adapter for wired charging.

[0231] Fig.68CA cross-sectional view of a device 600 is shown, the device 600 includes a display 6012, a pcb 6007, and a CMUT 6004 as a sensor. Optionally, the device may also include a charging coil for wireless charging, or the device may include an adapter for wired charging. Optionally, the device may also include a laser, a camera, etc., to assist in positioning the puncture site 6008 on the patient's skin surface.

[0232] See now Figure 69A-C , which shows a device 7000 according to another embodiment of the present disclosure. The device 7000 is substantially similar to the device 5000, and thus similar elements are referred to by similar numbers within the 7000 series of numbers. The device 7000 has an ergonomic handle 7026 that can be rotatably deployed to help a user manipulate the device. Fig.69A As shown, the handle 7026 folds flat for storage, or can be raised slightly when not unfolded to double as a pocket clip for convenient carrying.

[0233] See now Figure 70A-C , which shows a device 8000 according to another embodiment of the present disclosure. The device 8000 is substantially similar to the device 5000, and thus similar elements are referred to by similar numbers within the 8000 series of numbers. The device 8000 includes an ergonomic knob 8026 that can be telescopically deployed to assist the user in manipulating the device. The knob 8026 allows two fingers to control the pressure / angle / traction of the device 8000. Optionally, the knob 8026 can be biased in an undeployed position so that it "clamps" onto the user's fingers during use to increase stability.

[0234] Fig.71A -D shows a device 9000 according to another embodiment of the present disclosure. Device 9000 is generally similar to device 5000, and thus like elements are referred to by like numerals within the 9000 series of numerals. Device 9000 includes raised "ramp" areas 9028 at either end of the device that can assist the user when pressing and sliding the device over the skin. The ramped end 9028 can also include an additional layer of friction inducing material such as a co-molded polymer (e.g., a thermoplastic elastomer (TPE)).

[0235] Fig.72A and Fig.72BDevice 10000 is shown according to another embodiment of the present disclosure. Device 10000 is generally similar to device 5000, and thus similar elements are referred to by similar numerals within the 10000 series of numerals. Device 9000 comprises a two-piece structure connected near one end with a hinge 10030, which can be rigid (spring, door hinge, etc.) or semi-flexible (living hinge, elastic material, etc.).

[0236] Each part may be thinner than the one-piece embodiment described above, and various components of the device may be located within one of these parts. One such configuration is Fig.72A Shown in.

[0237] like Fig.72B As shown, the two-piece structure allows a user to slide the device 10000 onto the edge of a pocket for easy carrying. The teeth 10032 can enable the device to engage the edge of a shirt pocket (or other structure where the device will be clamped on the edge of a shirt pocket) by sliding the curved surface of the teeth against the edge to move the edge between the parts to become engaged therein.

[0238] Fig.73A and Fig.73B Device 10100 is shown in accordance with another embodiment of the present disclosure. Device 10100 is substantially similar to device 10000 and thus similar elements are referred to by similar numerals within the 10100 series of numerals. Device 10100 includes a two-piece structure connected near one end to a hinge 10130, which may be rigid (a spring, a door hinge, etc.) or semi-flexible (a living hinge, an elastic material, etc.). The hinge may be biased so as to bring the two layers together. Hinge 10130 is further inboard than the hinge of device 10000 so that a user can more easily squeeze the hinge end to separate the two parts for easy clipping to a pocket or other structure, such as Fig.73B shown.

[0239] Figure 74A-Figure 74C Device 10200 is shown according to another embodiment of the present disclosure. Device 10200 is substantially similar to device 10100, and thus similar elements are referred to by similar numbers within the 10200 series of numbers. Device 10200 comprises a two-layer structure, wherein the two layers are connected in an arrangement via extendable posts 10232. Posts 10232 may be as follows: Fig.74C As shown, it is telescopic or otherwise longitudinally expandable, or it can have Fig.74A and the pivotal or hinged relationship of the two layers shown in B. Post 10232 can be biased inwardly toward bringing the two layers together so that a user can engage the opposing curved edges of the two layers and force her fingers between the layers, thereby separating the fingers, as shown in FIG. Fig.74BAs shown. The biasing action provides the device 10200 to actively grip the user's finger for stability during use. Alternatively, the column 10200 may include a ratchet mechanism to maintain a gap controlled by the user. For example, the two layers can be spread away from each other, and when the user places her finger between the layers, the layers can move back toward each other along the ratchet and be positioned (and clamped) in a position that comfortably seats the layers against the finger. In the above variation where the layers are biased toward each other, the column can incorporate a damper that can slow the movement of the layers toward each other.

[0240] As with any of the embodiments disclosed herein, which include a biasing or ratcheting portion, or a knob or other handle, such a structure can allow a user to be stably connected to the device during use, and further, because such a structure secures the device to the user, can allow the user to lift the device off the patient's skin without having to better grip the device. Similarly, with the device securely attached to the user's finger, it can be easier to apply counter-traction on the patient's skin, which can help stabilize the vein while using the thumb (since the thumb does not need to grip the device), and can also help prevent the user from accidentally dropping the device.

[0241] Figure 75A-Figure 75C Device 10300 is shown in accordance with another embodiment of the present disclosure. Device 10300 is substantially similar to device 5000, and thus similar elements are referred to by similar numbers within the 103000 series of numbers. Device 10300 includes an incision 10336 at a location where needle 10306 can enter the skin, similar to the other exemplary embodiments discussed above. Fig.75B As shown, the incision 10336 can be any desired size to expose the puncture site 10308. Sensors positioned on the two legs 10337 of the device (on either side of the incision 10336) can sense the area of ​​the patient within the incision to better image the needle 10306 when it first enters the skin at the puncture site 10308.

[0242] Additionally, the inner surface of the incision 10336 can be mounted with a camera, metal sensor, or other surface sensor described above to better image the needle before and / or when the needle first enters the skin at the puncture site.

[0243] See now Fig.76A and Fig.76B, which shows a device 10400 according to another embodiment of the present disclosure. Device 10400 is substantially similar to device 5000, and thus similar elements are referred to by similar numbers within the 10400 series of numbers. Device 10400 includes a sensing layer 10404 and a display 10412, wherein the sensing layer 10404 is positioned adjacent to or on the patient's skin and wherein the sensing layer is positioned at an angle relative to the display. Such positioning of the display can provide a viewing screen at a more perpendicular angle to the user's eyes, thereby allowing improved and more accessible viewing, particularly where the user is sitting in a chair close to the patient or otherwise positioned to the side of the puncture site and the device. The angle can be any desired angle, such as between and including about 1 degree and about 90 degrees.

[0244] The user can place their finger on top of the sensing layer 10404, resting on the ergonomic texture 10440 ( Fig.76A ) and / or concave or recessed surface 10442 ( Fig.76B ). The textured gripping surface 10440 may be formed of a high traction material (e.g., a high friction rubber pad). Note that Fig.76B Cut away to show the CMUT sensor 10404 (or other sensors). The device 10400 may also include a notch 10411 , similar to the other notches and cutouts discussed above, which may provide space for a needle to enter a puncture site that may be located proximate to the CMUT sensor array 10404 .

[0245] Figure 77A-Figure 77C Device 10500 according to another embodiment of the present disclosure is shown. Device 10500 is substantially similar to device 10400, and thus similar elements are referred to by similar numbers within number series 10500. Device 10500 includes a sensing layer 10504 and a display 10512 that are angled relative to each other. The device of this embodiment also includes a knob 10548 on the device (positioned on top of the sensing layer as shown) for engagement by a user. Thus the user can place his finger between the layers, wherein the ergonomic knob helps the user manipulate the device.

[0246] like Fig.77B and Fig.77A As shown, knob 10548 can be foldable to simplify storage or widen the possible ways of using the device. As described above, the knob can be telescopically or otherwise expandable and can be biased toward a specific position (such as a folded position).

[0247] Figure 78A-78CDevice 10600 is shown according to another embodiment of the present disclosure. Device 10600 is substantially similar to device 10500, and therefore similar elements are referred to by similar numbers within the 10600 series of numbers. Device 10600 includes a sensing layer portion 10604 and a display portion 10612, however, these portions are connected via a hinge 10652, which can be rigid (spring, door hinge, etc.) or semi-flexible (living hinge, elastic material, etc.). Hinge 10652 can be biased so as to bring the two layers together. Alternatively, the hinge can include a ratchet so that the two portions will be maintained at a constant set angle relative to each other.

[0248] When using 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 another and then placing one or two fingers between the separated portions.

[0249] In an alternative where the hinge is biased, the two parts can be tightly closed around a finger. Optionally, the hinge can be blocked so that the closing motion is slow and controlled. On the contrary, in a variation of the ratchet hinge, the user can close the parts around his (one or more) fingers to position the device tightly on the user's hand. In addition, the inner surface of each part can include a grip 10654 or other ergonomic material / shape to provide additional stability to the device during use. For example, a soft high-traction material can help secure the device to a finger. The hinge can be able to obtain any angle desired between 0 degrees and 180 degrees and including 0 degrees and 180 degrees (e.g., between about 1 degree and about 90 degrees and including about 1 degree and about 90 degrees).

[0250] Figure 79A-79H Various embodiments of notches 5011 or other targeted features for providing access to the puncture site 5008 and / or providing guidance for the needle 5006 to the puncture site are shown. Fig.79A An exemplary targeting device is shown, i.e., a laser 10700, spotlight, etc., which highlights 10702 the desired puncture site 5008. The light position 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 recognition of the patient's underlying anatomy.

[0251] exist Fig.79BIn another embodiment shown, the mechanical indicator 10800 is represented as at least one, and as shown three, physical markings that point to a middle position 10802 in the notch of the device. The device user can utilize these (one or more) markings to guide the needle toward the skin in the notch and to the puncture site 5008 located therein.

[0252] exist Fig.79C In another embodiment shown, the device may include a light-based targeting device 10900 whereby the puncture site 5008 is indicated on the skin with the aid of projected illumination 10902 (e.g., laser dot, projected light crosshairs, laser line, etc.) The location on the patient's skin may be constant and fixed relative to the device, or alternatively may be movable based on the device's software and its recognition of the patient's underlying anatomy.

[0253] In another embodiment, the device may include a Fig.79C The light-based targeting device 11000 is described, but as shown, the projected illumination 11002 also includes a line 11004 projected by the device onto the patient's skin. The line can also help the user align and aim the needle along the correct XY path before the needle contacts the skin at the puncture site 5008.

[0254] In such Figure 79E-79G In another embodiment shown, the device 5000 may include connectivity capabilities 12002, such as Bluetooth, for wirelessly connecting to a needle element 12004. The needle element can be attached to the needle 5008, or integrated into the needle, and wirelessly connected to the device (e.g., with Bluetooth functionality). The needle element 12004 can be an accelerometer or gyroscope, or other sensor device. In the example of an accelerometer or gyroscope, the accelerometer can determine the position of the needle 5008 relative to the device. Via the Bluetooth connection, the device can determine the directional axis of the needle's aiming, the intersection of the axis with the skin surface (particularly the puncture site), etc., and such information can be used to generate an image (as described above) and / or data about the position of the needle on a display of the device. The needle element 12004 can be as shown in FIG. Fig.79E and Fig.79F It is shown simply clipped onto the needle 5008, or may have another attachment mechanism to secure to the body of the needle.

[0255] exist Figure 79HIn another embodiment shown in , the device includes at least one sensor 13002 above the skin (e.g., below the screen, or as shown, on the inner surface of the leg surrounding the incision) that can determine the position and axis angle of the needle tip 5010 before the needle tip contacts the skin. These sensors can be vision / camera based, or sense the metal of the needle (e.g., via magnetism). A virtual representation 13004 of the needle can appear on the screen before the needle is inserted into the skin, so the needle can be visually aligned with the subsurface vein XY that appears on the screen (even if the actual tip of the needle is obscured from the user's direct line of sight). Once below the skin and through the puncture site, the needle can still be viewed on the screen via other sensors on the device, such as the CMUT sensor.

[0256] Any of the above devices may also include a pad or other intermediate layer that can be positioned between the bottom surface of the device and the skin. An example of such a pad 14000 is shown in Figure 80A-80C 14004 to enhance visualization. A peel-off cover 14002 can protect the gel 14004 prior to use. The liner can also impart sterilization, marking / targeting, or other features to the device. In addition, while the device can be reusable, the gel liner can be disposable. The layers can be peelable to allow an operator to remove a used layer to reuse the liner, or to remove an unwanted layer to customize the liner to a patient's specific needs.

[0257] Navigation / Imaging

[0258] As described above, the device of the present invention includes various functions suitable for semi-autonomous or autonomous use, for example, locating the puncture site on the patient and inserting the needle into the patient. Regarding the function of locating the puncture site, the device may include a navigation capability to help internal visualization to locate the puncture site. The navigation capability may examine the patient's anatomical structure in a manner to search for a desired blood vessel. For example, navigation may include sensors utilizing ultrasound, X-rays, infrared ("IR"), near infrared ("NIR"), diffuse IR, acoustics, photoacoustics, photoacoustics, light emitting diodes ("LED"), CMUT, polarized LED, cameras, transillumination or other technologies. Sensors using different technologies may also be combined in a single device. For example, a transillumination sensor may serve as a first visualization tool to quickly provide preliminary visual data on a large vein location, which in turn will allow the operator to place the device on a common vein location and use a secondary sensor to partition and pin the puncture site point. The secondary sensor may be an ultrasonic sensor, which will provide accurate and detailed imaging information. The dual sensor approach will optimize navigation performance by balancing speed and accuracy. Regardless of the type of sensor, the navigation sensor can be fully translatable in an autonomous device having six degrees of freedom that can automatically scan a patient's skin area once the device is placed on the patient's skin area. A semi-autonomous device can have a fixed or partially translatable navigation sensor. For example, a semi-autonomous device with an ultrasound navigation sensor can include a first lateral array and a second lateral array of ultrasound transducers to perform 3D mapping of veins.

[0259] The navigation output can be communicated to the operator visually, auditorily or tactilely. A visual display can be provided by a GUI on the device or transmitted to a remote display screen, which can show a three-dimensional map of the blood vessels and the general subcutaneous conditions at the puncture site. As needed, this map can include dynamic (real-time) imaging and / or static imaging. For example, real-time imaging can be obtained at the puncture site to monitor insertion by placing the navigation sensor directly in the line of sight of the area, while static imaging can be used to generate a map of a larger area to improve visual feedback to the operator. The visual display can also be projected directly on the skin surface, thereby indicating (one or more) puncture sites with reference to the drawn veins, and enhanced with laser or other light projection as puncture site guidance. Image amplifiers, contrast resolution adjusters and other image optimization features can also be included to enhance visual feedback. Further, auditory and tactile output feedback can also be integrated with the visual display to improve the user interface. For example, auditory signals can also be incorporated into the device and used in conjunction with the visual display to further assist in the precise positioning of the puncture site. For example, as explained above in the dual sensor approach, the first sensor output may be communicated solely via auditory signals, thus allowing the operator to quickly narrow down the puncture site for the second sensor scan without any visual display feedback.

[0260] Navigation capabilities will include not only the ability to identify the location of veins beneath the skin and the depth of veins, but also the ability to identify other key aspects of blood vessels and blood flow. For example, Doppler ultrasound can be used to detect and display blood flow direction and blood flow conditions. This will enable the operator to distinguish between arteries and veins based on the direction of flow, and evaluate blood flow conditions such as velocity, pressure, and temperature to accurately identify the puncture site autonomously. Alternatively, the device may be able to process this information to identify and guide the operator to the puncture site in a semi-autonomous manner. A nerve monitor may be included in the device to detect the proximity and location of the nerve, and ensure that the puncture site and trajectory are spaced apart from the nerve. Venous valves and bifurcations can be identified and evaluated when determining the ideal puncture site.

[0261] 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 may relay data about successful needle puncture and may supplement visual feedback obtained from other sensors. Force sensors and tactile sensors may be particularly useful during access to wrist veins and other similar vein locations to provide tactile feedback to avoid excessive insertion force that may result in needle penetration of the vein.

[0262] In addition, a velocity sensor or pressure sensor can be coupled to the device to allow the operator to ensure that the needle remains securely in place after insertion. For example, if the needle accidentally moves out of the blood vessel after insertion, these sensors can detect changes in blood velocity or blood pressure and alert the operator.

[0263] Although the navigation capabilities disclosed herein are generally discussed with reference to the circulatory system, they can also be used in subcutaneous and intraosseous needle injection procedures. Similar navigation systems can be used for such procedures.

[0264] In certain locations on the patient's body, the target blood vessels may be in relatively extreme positions such as being particularly deep and / or very shallow. For example, the anatomy of the hand includes blood vessels at these locations, particularly superficial and very close to the skin surface. In order to produce additional viewing depth for these superficial veins, the housing and imaging system may be further spaced apart from the skin surface by using a thicker coupling material or an extended or expanded coupling material. The coupling material may include a hydrogel or another water-based substrate suitable for transmitting ultrasound with minimal loss or distortion. The coupling material may be manually changed, for example, by selecting a thicker or thinner coupling pad according to the depth of the vein. The thickness or properties of the coupling material may also be compressible or dynamically adjustable, driven by a motor, pump, heat transfer, etc., causing the coupling material to expand or change shape. Alternatively, the coupling film may include shape memory properties, such as a retractable supramolecular hydrogel, etc.

[0265] While some devices such as devices 10, 20 used herein allow the housing 100, 400 to be moved around the skin surface by an operator, some embodiments do not have this capability for various reasons. For example, in addition to the various sensors discussed above, in some instances the navigation system may also have the ability to mechanically move the housing along the skin surface. For example, the Figure 3A-3B The device 30 includes a base 800 that is fixed to the patient so that the base 800 does not move. Therefore, the housing 700 includes the ability 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 can be automated or can be controlled by an operator using a GUI or the like. As discussed above, the navigation sensor used in this embodiment can be any desired.

[0266] In other embodiments, for example Figures 4A-6B Such devices include a housing that is movable relative to a base to perform at least a navigation function to scan the patient's anatomy and determine at least one puncture site. Figure 9A-9B Another example of such a device is shown, where the housing 900 has at least one degree of motion, as shown, the housing 900 can rotate relative to the base 1000 in a direction R', such as Fig.9E As shown. The base 1000 may be similar to Figure 1A-Figure 2E The base 200, 500 of the present invention, instead of the base and the housing being attached so that they cannot move relative to each other, the base 1000 includes a rotatable connection to the housing 900. Once the base 1000 is secured to the patient at a generally desired location, and the rotatable connection is achieved by any desired attachment mechanism (e.g., adhesive, strap, etc.), the housing 900 can be scanned along the patient's skin surface for at least one puncture site in a general area. As discussed above, the navigation function of the housing 900 can be autonomous or semi-autonomous through the operator's section.

[0267] also, Figure 9A-9D and Figure 9G-Figure 9I 901 and at least one side surface 902 or 903 of the housing 900 may include a screen that can be a GUI and thereby display the underlying anatomical structure to the user. As shown, the top surface 901 can be viewed from the top (i.e., from the z direction, such as Figure 9G ), and at least one side surface 902 can be viewed from the side (i.e., from the y direction, such as Fig.9I The ability to show two views can provide the user with improved viewing, which can lead to more accurate positioning of the needle. Alternatively, one or both of the displays can also show a cross-sectional view (i.e., from the x-direction, such as Figure 9H Alternatively, any display on housing 900 can be switched between any of these views.

[0268] Figures 10A-10E , Figure 11A-11C , Figure 12A-12C , Figure 13A-13B Additional embodiments of GUIs are shown, and if the GUI is present on the device, the user can interact with the device of the present disclosure. Although the following embodiments are examples of what types of information can be displayed on the GUI, other variations or even combinations of various embodiments can be envisioned. In addition, it is envisioned that the GUI can be customized by the operator during manufacture or before use to display information desired by a particular operator. A GUI according to the present disclosure can include various renderings of the display to facilitate imaging and / or surgery. For example, different colors can be used to represent different body parts such as veins, nerves, arteries, etc. to enhance the display of these body parts. A color scheme representing a body part can be customized or provided according to standard medical practice.

[0269] In one example of such a navigation system, Figure 10A-10EAn exemplary GUI on housing 100 is shown. The GUI provides representative images of blood vessels 1, 2 in the circulatory system and a representation of needle 301. As shown in this example, vein 1 and artery 2 are both located via the navigation capabilities of housing 100 and shown in a cross-sectional view, and needle 301 is then guided 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. Figure 10D-10E As shown, the GUI may also be placed on the tourniquet to provide information to the user at the tourniquet in addition to or instead of displaying information on the housing GUI itself.

[0270] Figure 11A-11C Another embodiment of the present disclosure is shown, in which blood vessels 1, 2, 3 are shown in a bird's eye or top view, and a needle 301 is represented as an arrow. In this example, three potential puncture sites are designated by dashed lines 11, 12, 13 along specific lengths in the respective blood vessels. The GUI of this example includes a box shown at dashed line 11 on blood vessel 1, which specifies which position has been selected for the inserted needle (e.g., Fig. 11C In this example, housing 100 includes the ability to determine the depth of location 11 on blood vessel 1 and extrapolate to a puncture site on the patient's skin surface (not shown), which can be positioned adjacent to base 200. Fig. 11B As shown, once position 11 is designated by the selection box, in the case of a semi-autonomous system, the operator can interact with housing 100 to initiate needle insertion. As shown, this interaction can be performed using a button 302 on the GUI (designated as a swipe button 302 in this example), although other forms of interaction are contemplated. Then, Fig. 11C The final insertion position of needle 301 is shown, which is now shown as an elongated arrow to show the length of needle 301 within blood vessel 1. As described above, any desired information (such as battery life, needle gauge, blood vessel diameter, etc.) can also be displayed on the GUI or elsewhere on housing 100 (or a separate interface).

[0271] Figure 12A-12C Another embodiment of the present disclosure is shown, which shows how the housing 100 can have the ability to switch between multiple views, including, for example, cross-sectional views ( Fig. 12A ) and a bird's eye view or top view ( Fig. 12B ). Fig. 12C and Fig. 11C The complete insertion of needle 301 is similarly shown. Figure 11A-11C As discussed, this embodiment may similarly include, for example, various information displayed on the GUI, a dashed line 11 designating a suggested insertion position for the needle 301, and a pointer indicated by an arrow ( Fig. 12B) and thin needles ( Fig. 12C ) for a representation of needle 301. Depending on the size of the display on housing 100, the display may provide split-screen viewing so that, for example, a cross-sectional image and a top view image may be shown simultaneously. This capability may be particularly useful in operator-guided or assisted needle insertion operations (i.e., semi-autonomously) because the multiple screens provide a more intuitive and realistic visual depiction of the blood vessel, thereby enabling the operator to accurately position the needle in the patient's blood vessel.

[0272] Figure 13A-13B Another embodiment of the present disclosure is shown, where, in this example, the housing 100 includes a GUI having the ability to display an ultrasound image and information overlaid on the ultrasound image. Figures 11A-12C As with the graphical representation of FIG. 7 , the ultrasound image may include a cross-section 77 ( Fig.13A ) and top or side view 78( Fig. 13B ) display, along with various overlay information such as size, scale, location coordinates, battery life, etc.

[0273] Fig.14 An embodiment of how the visual display (GUI) 430 of the present disclosure will utilize an ultrasound sensor as part of its navigation system is shown. The ability to display ultrasound images of the device can include the generation and depiction of a two-dimensional view or a three-dimensional view of the patient's anatomical structure. The two-dimensional image can usually generate views of the x-direction and y-direction 431, 432, 433 by including two separate ultrasound scanners in the shell, and the operator can switch between the two separate ultrasound scanners to generate a cross-sectional view and a longitudinal (side or top) view, or these views are displayed separately on a multi-faceted display. A three-dimensional ultrasound image can be generated by incorporating another probe in the z direction, or alternatively, by providing another degree of freedom relative to the patient's shell. The visual display (GUI) can be a normal ultrasound imaging depicting various areas based on echo intensity, where a white layer is used for strong echoes and a black layer is used for weak echoes, whereby the navigation system processes the ultrasound information to generate a graphical color representation of the insertion area that allows improved visual feedback.

[0274] Fig.15 Provides similar Fig.14 Still another embodiment of a GUI 530 of the present invention can provide multiple views on different surfaces. In this embodiment, the surface of the device is curved so that different views are displayed along different portions of the curved surface (as shown, z-direction views and y-direction views, but other configurations are possible). The surface of the device can be a single, continuous GUI, or the GUI can be divided into multiple screen locations along specific portions of the curved surface.

[0275] In another 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 for children. For example, the device may include two different displays depending on the direction of viewing. For example, a visualization of the above-mentioned anatomy will be seen from the operator's perspective, while a pleasing picture will be seen from the patient's perspective to calm the patient. Alternatively, in an embodiment where the device operates autonomously, since such a GUI is not needed, the GUI may still be included on the housing so that the patient can view animations, videos, or video games during the needle insertion process to act as a distractor. In some cases, the video game or animation may be consistent with the needle insertion process.

[0276] See now Fig.32 , which shows a visualization device 100' according to one embodiment of the present disclosure. The visualization device 100' includes a probe surface 102', a plan view display 104', and a first depth view display 106' and a second depth view display 108'. As described more fully below, the probe surface 102' includes a plurality of transducers to generate a two-dimensional image of a volume 10' representing a target body region within a patient. The volume 10' is located below a skin surface 12' and has a length 14', a width 16', and a depth 18' along Z, X, and Y axes, respectively, as represented by direction reference 11'. Fig.32 As shown, the dimensions of the plan view display 104' and the probe surface 102' are substantially the same as the width 16' and the length 14' of the volume 10', respectively. Therefore, the probe surface 102' defines an area sufficient to generate a two-dimensional image to cover the volume 10'. Similarly, the first depth view display 106' and the second depth view display 108' correspond to the volume 10'. Other embodiments may have different display screen sizes. For example, the displays 104', 106', 108' may be configured to be larger than the corresponding dimensions of the volume 10' to provide an enlarged view of the volume 10' for improving the visibility of the target body area. The transducers on the probe surface 102' may be configured to generate ultrasonic communication according to the visualization needs of the target body area and the target body area to change the depth 18'.

[0277] Although in Fig.32, a visualization device 100' is shown having a generally rectangular shape, but other embodiments may have various other shapes as described more fully below. Similarly, the volume 10' may also have different shapes depending on the probe surface 102' and the transducer positioned thereon. The visualization device 100' may be configured as a stand-alone device that includes all other components such as a power source (battery), circuitry required to operate the transducer, image processing that combines the two-dimensional images generated by the transducer into a three-dimensional view of the volume 10', etc. In other embodiments, the visualization device may be configured to be connected to an external power source or a remotely located image processor. The image processor includes an advanced graphics processing unit ("GPU") configured to generate three-dimensional visualizations in real time. A visualization device configured to interface with external components will reduce the overall size and dimensions of the visualization device.

[0278] Fig.33 A visualization device 100' is shown placed on a patient's forearm to assist in a cannula insertion procedure. Volume 10' covers the relevant insertion area including veins and nerves beneath the skin 12'. Fig.34A As best shown in FIG. 1 , the plan view display 104 ′ shows a plan view of the volume 10 ′ when the visualization device is placed such as in FIG. Fig.33 As shown on a forearm, the volume 10' includes veins 20', venous branches 24', and nerves 22' that are currently located below the skin surface 12'. Fig.34B A first depth view display 106' is shown showing a depth view of the vein 20', vein branches 24', and nerves 22' along the Z-axis and the Y-axis. Fig.34C A second depth view display 108' is shown, which shows veins 20' and nerves 22' along the Y-axis and X-axis. Thus, the visualization device 100' provides the operator with a real-time three-dimensional view of the veins and nerves to allow accurate cannulation. Other details of the target body area (such as blood flow direction, valves, tissue conditions, etc.) can also be displayed on displays 104', 106' and 108'.

[0279] See now Fig.35A and Fig.35B , which shows a visualization device 100' placed at two different locations on a patient's body. As shown here, the visualization device 100' is placed at two exemplary locations—a patient's bicep and a patient's wrist. Placing the visualization device 100' at these various body locations can allow an operator to instantly view a three-dimensional visualization volume 10' located beneath the visualization device 100'.

[0280] Fig.36A and 36BA visualization device 200' is shown according to another embodiment of the present disclosure. The visualization device 200' is similar to the visualization device 100', and thus similar elements are referred to by similar numbers within the 200' series of numbers. 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 band or tourniquet having a frame 218', such as Fig.36A As shown. The attachment device 216' is configured to wrap around an arm or other area of ​​the patient. The frame 218' is configured to removably house the displays 204', 206', 208' and the probe surface 202'. The visualization device 200' includes a tracker 214' connected to the frame 218'. The tracker 214' may include a plurality of tracking elements 217', which are configured to position the attachment device 216' with reference to the volume 10'. As such, once the volume 10' is visualized in three dimensions, the tracker 214' can provide the three-dimensional coordinates of any point in the volume 10'. As shown Fig.36B As shown, the displays 204', 206', 208' and the probe surface 202' can be detached from the attachment device 216'. The tracker 214' transmits the three-dimensional coordinates of the volume 10' in real time via a direct or remote connection 230'. The remote connection mechanism can 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 displayed in real time on the first depth view display 206'. An imaging device or tracking device such as a camera can be used to track the position of the cannula 215 in the volume 10. Therefore, the visualization device 200' allows the operator to accurately position the cannula 215' within the patient's vein.

[0281] See now Fig.37 , which shows a visualization device 300' according to another embodiment of the present disclosure. The visualization device 300' is similar to the visualization device 100', and thus similar elements are referred to by similar numbers within the 300' series of numbers. For example, the visualization device 300' includes a plan view display 304' and a first depth view display 306'. However, as Fig.37 As best shown in FIG. 3 , the visualization device 300′ includes a curved screen 320′. The curved screen 306′ may be rigid and specifically adapted to fit a body area, or may include a flexible detection surface area 302′ (not shown) to allow the visualization device 300′ to be properly placed over a target body area. An operator may view a plan view and multiple depth views on the curved display 320′.

[0282] Fig.38A and 38BA visualization device 400' is shown according to another embodiment of the present disclosure. The visualization device 400' is similar to the visualization device 300, and thus like elements are referred to by like numerals within the 400 series of numerals. For example, the visualization device 400' includes a curved display screen 420'. However, the visualization device 400' includes a parallax viewing capability whereby the position of a viewer can be tracked by a camera 425' or other device (such as a sensor), and a corresponding volumetric three-dimensional view can be displayed on the curved screen 420' relative to the viewer's position. For example, when the viewer is in position 422', the camera 425' tracks the viewer's position and displays the plan view 404' to correspond to the viewer's position. Fig.38A Similarly, when the viewer moves to position 426', camera 425' locates that position and displays the first depth view display 406' on the curved screen 420' to align with the viewer's field of view 428', as shown in FIG. Fig.38B 420', 426', or any position therebetween.

[0283] Fig.38C and Fig.38D Another embodiment of a parallax view on a visualization device 100' is shown. It should be noted that the parallax view concept described herein can be used in conjunction with any visualization device. A viewer at position 1, 2, or 3 observes a unique three-dimensional perspective of the volume 10' specific to each position. For example, when the viewer is at position 1, the viewer observes a three-dimensional plan view display 104', such as Fig.38E Similarly, when the viewer moves and is positioned at position 1 or 2, the viewer observes the three-dimensional third depth view 110' or the three-dimensional first depth view 110'. Fig.106 ', such as in Fig.38F and Figure 38G Thus, as described above, based on the movement of the viewer (such as the user's eye movement), the display will update accordingly to provide a specific visualization of a specific location and movement of the viewer. The display screen displaying the parallax view may include a touch-sensitive screen surface, whereby the user can Fig.55The display can be slid as shown by the directional arrow 121' in the figure to rotate the view for parallax-enabled depth perception. In another embodiment, the visualization device can display only the cross-sectional view on each display. For example, the display surfaces 108', 106' and 104' will each display only the cross-sectional view corresponding to each display, that is, this embodiment may not include any three-dimensional perspective view.

[0284] See now Fig.39 , which shows a visualization device 500' according to another embodiment of the present disclosure. The visualization device 500' is similar to the visualization device 100', so similar elements are referred to by similar numbers within the 500' series of numbers. 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', which has a probe surface 502' separated from the displays 504', 506' and 510'. The probe body 511' is configured to be placed in an opening 532' of an attachment device 516'. The attachment device 516' may include a base, such as a frame 518' and a belt 534' as shown in the figure, which can be fixed to the patient's body. Since the probe body 511' of the visualization device 500' does not include a display screen, the size and dimensions of the probe body can be smaller than a visualization device including a display. Once probe body 511 ′ is placed in opening 532 ′, probe surface 502 ′ may generate a three-dimensional visualization of volume 10 ′ and transmit the three-dimensional visualization of volume 10 ′ to displays 504 ′, 506 ′, and 510 ′ via link 530 ′ to show a real-time three-dimensional visualization of volume 10 ′.

[0285] Fig.40 A transducer array 600' is shown on a probe surface 602' in accordance with an embodiment of the present disclosure. The transducer array 600' may be used 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'. Ultrasonic transducers or ultrasonic sensors such as capacitive micromachined ultrasonic transducers ("CMUTs"), ultrasonic transducers, piezoelectric transducers, and the like 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 specific body area being visualized. When a CMUT is used, the substrate 604' may be a silicon substrate. The CMUT may be placed within a cavity in the silicon substrate 604'. The transducer 602' is configured to switch between a transmit mode and a receive mode to generate and capture ultrasonic reception. An algorithm may be used to activate individual CMUTs and switch them between transmit mode and receive mode as needed. As Fig.40 As best shown in , the projected area of ​​the transducer array 600' is substantially the same as the surface area of ​​the volume 10' defined by the length 14' and the width 16'. Thus, a three-dimensional visualization of the volume 10' can be generated by placing the transducer array 600' at the body region.

[0286] See now Figure 41A-41C , which shows the creation of a three-dimensional visualization of a volume 10' utilizing a transducer array 600'. Active transducers 602" (ie, transducers in either transmit mode or receive mode) may include a single transducer, a row of transducers, or the entire transducer array 600'. Fig.41A An active transducer row 602' is shown generating a two-dimensional image 636' of a two-dimensional slice of a capture volume 10'. The depth 18' of the two-dimensional image 636' depends on the type of transducer 602' and the power supplied by the transducer 602'. Both parameters can be appropriately changed depending on the application of the visualization device. For example, low power transmission through a coarse transducer array can be used to generate a two-dimensional image with low depth penetration, and high power transmission through a fine transducer array can be used to generate a two-dimensional image with greater depth penetration. The density of the transducers 602' on 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 A second row of transducers 602' is shown being activated to generate a two-dimensional image 636' at a second location. As described above, the rows may be activated individually or simultaneously, such as Fig.41C After generating a two-dimensional image 636' from one side of the volume 10 to the other, the two-dimensional image acquisition 638' is then processed by an image processor housed within or external to the visualization device to create a three-dimensional visualization of the volume 10'.

[0287] Fig.42 7 is a transducer array 700' according to another embodiment of the present disclosure. Transducer array 700' is similar to transducer array 600' and thus like elements are referred to by like numerals within the 700' series of numerals. For example, transducer array 700' includes transducers 702' arranged in substrate 704'. However, transducer array 700' has transducers 702' along a width 16' of volume 10' to generate a two-dimensional image along the width in some applications rather than along the length as discussed above.

[0288] Fig.438 is a transducer array 800' according to another embodiment of the present disclosure. Transducer array 800' is similar to transducer array 600' and thus like elements are referred to by like numerals within the 800' series of numerals. For example, transducer array 800' includes transducers 802' arranged in a substrate 804'. However, transducer array 800' has transducers 802' along both the length 14' and the width 16' of volume 10'. This allows transducer array 800' to generate two-dimensional images in multiple directions for high resolution three-dimensional visualization of volume 10'.

[0289] Fig.44 900' is a transducer array according to another embodiment of the present disclosure. Transducer array 900' is similar to transducer array 600', and thus like elements are referred to by like numbers within the 900' series of numbers. For example, transducer array 900' includes transducers 902' arranged in a substrate 904'. However, transducer array 900' has transducers 902' that are diagonally sized to generate a two-dimensional image.

[0290] Fig.45 1 is a transducer array 1000' according to another embodiment of the present disclosure. Transducer array 1000' is similar to transducer array 600', and thus similar elements are referred to by similar numerals within the 1000' series of numerals. For example, transducer array 1000' includes transducers 1002' arranged in substrate 1004'. However, transducer array 1000' does not cover the entire probe surface area as described in the previous embodiments. Transducers 1002' are strategically placed to allow ultrasound signals to be projected onto the probe surface area to cover volume 10' without requiring the transducers to be positioned directly above every location on volume 10'. This can be as Fig.45 This is accomplished as best shown in FIG. 1 , where the gaps between transducer rows 1003 ′ are configured to be covered by transducers 1002 ′ that are selected to transmit and receive ultrasound signals in multiple directions.

[0291] Fig.46 1 is a transducer array 1100' according to another embodiment of the present disclosure. Transducer array 1100' is similar to transducer array 600', and thus similar elements are referred to by similar numbers within the 1100' series of numbers. For example, transducer array 1100' includes transducers 1102' arranged in substrate 1104'. However, transducer array 1102' is configured to move around the probe surface area as indicated by directional arrows 1104'. Therefore, the transducer array size 1102' can be significantly smaller than the previous fixed transducer arrays described above. The resolution and coverage of volume 10' can be controlled by controlling the speed of transducer array 1102' over the probe surface area.

[0292] Fig.47 1 is a transducer array 1200' according to another embodiment of the present disclosure. Transducer array 1200' is similar to transducer array 1200', and therefore similar elements are referred to by similar numbers within the 1200' series of numbers. For example, transducer array 1200' includes transducers 1202' arranged in a substrate 1204'. However, substrate 1204' in this embodiment is circular and is configured to be placed around a body region of a patient. Transducer 1202' is configured to move around a probe surface region along a circular path 1206' as indicated by directional arrow 1205'. Therefore, a volume 10', which is defined as an area within the probe surface region, is covered by the mobile transducer array 1202'. Similar to transducer array 1100', transducer array 1200' only requires a small transducer array to generate a three-dimensional visualization of volume 10'.

[0293] Fig.48 is a transducer array 1300' according to another embodiment of the present disclosure. The transducer array 1300' is similar to the transducer array 600' and thus similar elements are referred to by similar numerals within the 1300' series of numerals. For example, the transducer array 1300' includes transducers 1302' arranged in a substrate 1304'. The transducer array 1300' includes slots 1310' to allow surgical procedures to be performed in an area of ​​the outer periphery of the substrate 1304' when the transducer array is placed on a target body area. The transducers 1302' adjacent to the slots 1310' are configured to cover a portion of the volume 10' directly below the slots 1302'. For example, the transducers 1302' adjacent to the slots 1310' can be angled directly toward the volume 10' below the slots, such transducers can have the ability to cover a larger portion of the volume 10' than other transducers, etc.

[0294] Fig.49 1 is a transducer array 1400' according to another embodiment of the present disclosure. Transducer array 1400' is similar to transducer array 1300', and thus similar elements are referred to by similar numbers within the 1400' series of numbers. For example, transducer array 1400' includes transducers 1402' disposed in substrate 1104'. Transducer array 1400' includes slots 1410' extending across the array to allow for surgical procedures to be performed while the transducer array is placed over a target body area. As described above with respect to Fig.48 As discussed, transducer 1402' adjacent to slot 1410' is configured to cover the portion of volume 10' directly beneath slot 1402'.

[0295] Fig.501 is a transducer array 1500' according to another embodiment of the present disclosure. Transducer array 1500' is similar to transducer array 1300', and thus like elements are referred to by like numerals within the 1500' series of numerals. For example, transducer array 1500' includes transducers 1502' disposed in substrate 1504'. Transducer array 1500' includes slots 1510' extending across the array to allow for surgical procedures to be performed while the transducer array is placed over a target body area. As described above with respect to Fig.48 As discussed, transducer 1502' adjacent slot 1510' is aligned and positioned to cover the portion of volume 10' directly beneath slot 1502'.

[0296] Fig.51 1 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 thus similar elements are referred to by similar numbers within the 1600' series of numbers. For example, the transducer array 1600' includes transducers 1602' arranged in a substrate 1604'. The transducer array 1600' includes a first block 1610' and a second block 1610", as shown in FIG. Fig.51 As shown, the first piece 1610' and the second piece 1610" can be flexed apart. The separated first and second pieces allow for surgical procedures to be performed while the transducer array is placed on a target body area.

[0297] Fig.52 1 is a transducer array 1700' according to another embodiment of the present disclosure. Transducer array 1700' is similar to transducer array 600', and thus like elements are referred to by like numbers within the 1700' series of numbers. For example, transducer array 1700' includes transducers 170'2 arranged in substrate 1704'. Transducer array 1700' is flexible and can be formed into any desired shape for placement on a particular body area.

[0298] Although various transducer arrays have been shown and described above, other configurations are also contemplated. For example, the substrate may have a low profile in any of the length, width, or height directions, depending on the application or intended use or anatomical structure in which the substrate will be used. In addition, any portion of the substrate and / or array may be planar, curved, tapered, etc., as desired, such that any substrate and / or array shape may be achieved.

[0299] See now Fig.53, which shows a flow chart depicting a method 1900' for performing cannula insertion using a visualization device 100' according to another embodiment of the present disclosure. Although the visualization device 100' is described herein, any other visualization device described or their various embodiments can be used to perform method 900'. The probe surface 102' is placed above the desired cannula insertion area. In step 1920', the transducers arranged on the probe surface area are activated by an algorithm to generate a series of two-dimensional images from one side of the volume 10' to the other side. The two-dimensional images are combined into a three-dimensional visualization by an image processor and shown on displays 104', 106' and 108'. In step 1930', the visualization device 100' can display additional details such as the projected cannula insertion position, the projected cannula insertion depth, and the projected cannula insertion path. The visualization device 100' can also display cannula insertion parameters such as cannula insertion point position, venipuncture position, insertion depth, venous blood flow rate, blood pressure, and temperature. In step 1940", the operator may evaluate the three-dimensional visualization and cannula insertion parameters and initiate cannula insertion. Cannula insertion may be performed manually or with the aid of a cannula insertion assembly. The visualization device 100' may track the position of the cannula during positioning of the cannula in the volume 10' to ensure accurate cannula placement.

[0300] Fig.54 A flow chart depicting a method 2000' for performing cannula insertion using a visualization device 200' is shown according to another embodiment of the present disclosure. Method 2000' is similar to method 1900' and includes the steps of placing the visualization device 200' on a cannula insertion area and generating a three-dimensional image of the volume 10'. However, once the three-dimensional image is generated in step 2020', the display and probe surface of the visualization device 200' are detached from the attachment device 216'. The tracker 214' transmits real-time three-dimensional data of the volume 10' to the display of the visualization device 200'. Cannula insertion can be performed manually or with the aid of a cannula insertion assembly. The visualization device 200' can track the position of the cannula during positioning of the cannula in the volume 10 to ensure accurate cannula placement.

[0301] Figure 56A-Figure 56C FIG. 2 shows a GUI display 2200′ according to another embodiment of the present disclosure. The GUI display 2200′ includes a virtual shadow 215″ of a cannula 215′ to facilitate three-dimensional perception of the spatial relationship between the skin insertion target, the vein insertion target, and the cannula 215′. Figure 56A-Figure 56C As shown, when the cannula 215' approaches the insertion target, the virtual shadow 215" converges toward the cannula tip 217'. During insertion, the cannula tip 217' and the virtual shadow 215" are in virtual contact, as shown in FIG. Fig.56C20', nerves 22', etc., to guide the cannula tip 215' to the desired insertion point. For example, the insertion area may be shaded in green, while the nerves may be shaded in red to allow the operator to reach the target area without inadvertently hitting objects to be avoided. The GUI display 2200' may include tactile or auditory feedback to the operator to assist in the insertion of the cannula 217' into the insertion area. In some embodiments, the GUI display 2200' may also include shaded areas to indicate areas or regions that have not yet been imaged by the probe surface.

[0302] Figure 57A-Figure 57C A GUI display 2300' is shown in accordance with another embodiment of the present disclosure. GUI display 2300' is similar to GUI display 2200', but GUI display 2300' includes a second virtual shadow 219'. As the cannula tip approaches the insertion zone, virtual shadows 215' and 219' converge toward the cannula tip 217'. The second virtual shadow 219' provides additional visual guidance to the operator for successful cannula insertion.

[0303] Figure 58A-Figure 58C GUI display 2400' is shown according to another embodiment of the present disclosure. GUI display 2400' is similar to GUI display 2200' and includes a virtual shadow 215'' of cannula 215'. However, as the cannula tip approaches the insertion zone, virtual shadow 215'' becomes progressively sharper and darker.

[0304] See now Fig.59 , which shows a GUI display 2500' according to another embodiment of the present disclosure. The GUI display 2500 detects an ambient lighting source 2502' near the visualization device and orients the virtual shadow 215" to match the ambient lighting source 2502' for a seamless depth perception effect. The GUI display 2500' helps prevent misorientation caused by deviations in the lighting angle in the room relative to the virtual lighting on the screen.

[0305] Figure 60A-60C GUI display 2600' is shown according to another embodiment of the present disclosure. GUI display 2600' includes cannula path indicator 2602'. Cannula path indicator 2602' depicts the projected path of cannula 215' through the skin and volume 10' according to the orientation of the cannula. For example, when cannula 215' is positioned as shown in FIG. Fig.60A When positioned as shown, skin insertion point 2604' and cannula path indicator 2602' are shown on GUI display 2600'. When the cannula is properly aligned with insertion vein 20', vein insertion point 2606' can be seen on GUI display 2600', as shown in FIG. Fig.60B and 60CGUI display 2600' indicates the suitability of vein insertion point 2606' based on the projected path of the cannula within vein 20', as depicted by path indicator 2608' (unsuitable) or 2610' (suitable).

[0306] Figure 61A-Figure 61C A GUI display 2700' is shown according to another embodiment of the present disclosure. The GUI display 2700' is similar to the GUI display 2600', and thus like elements are referred to by like numbers within the 2700' series of numbers. For example, the GUI display 2700' includes a cannula path indicator 2702', a skin insertion point 2704', and a vein insertion point 2706'. However, based on the cannula position and alignment of the cannula with the volume 10', the GUI display 2700' includes a projected distal tip of the cannula 2712'.

[0307] See now Fig.62 , which shows a GUI display 2800' according to another embodiment of the present disclosure. The GUI display 2800' displays an ideal cannula insertion point 2802' to assist in successful cannula insertion. Inappropriate insertion points, such as a venous region 2804' with sclerosis and a venous region 2806 directly below or above an artery 32', may be displayed on the GUI display 2800'.

[0308] Fig.63A – Fig.63D A GUI display 2900' is shown according to another embodiment of the present disclosure. The GUI display 2900' is capable of magnifying the displayed image of the volume 10'. The magnification can be performed manually by an operator to magnify and focus the image to a desired location (such as an 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' depicting magnification levels on the display screen.

[0309] Fig.64A and Fig.64B GUI display 3000' is shown according to another embodiment of the present disclosure. GUI display 3000' depicts depth perception by changing 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 Fig.64A Similarly, various color schemes and patterns can be used to indicate the relative depth of each of these elements in the Fig.64BThe relative depth of each element shown. It should be noted that any GUI display concept disclosed herein can be used individually or collectively in a visualization device. For example, GUI display 3000' can be used in conjunction with GUI display 2200', GUI display 2900' can be used in conjunction with GUI display 2800, etc.

[0310] Figure 101A-Figure 102B 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, such as Fig.102A and Fig.102B Best shown. The large surface area of ​​the visualization device 22000 provides sufficient coverage to visualize large anatomical features with a single placement of the device. In addition, the large display ensures that the visualized anatomical features are displayed in detail to allow appropriate imaging and / or manipulation to be performed at the surgical site.

[0311] like Fig.101A As shown, a belt 22002 having a pad 22004 is secured to a surgical site. The pad 22004 includes a gel 22206 and a fastening feature 22008 to allow easy attachment and detachment of the visualization device 22000. Fig.102A As best shown, when the visualization device is placed over the surgical site, the transducer array 22008 spans the ribs 22010. Each transducer of the transducer array 22008 transmits and receives a signal 22012 that propagates through the ribs 22010, the signal 22012 being spaced across the rib openings and diverging to cover the area beneath the ribs. Thus, all anatomical features beneath the ribs can be captured by placing the visualization device 22000 at a single location. Fig.102B The display 22014 shown in depicts ribs 22010 and soft tissue such as a heart 22016 located beneath the ribs.

[0312] Fig.103AA visualization device 22000 is shown that provides 3D, real-time imaging of a heart 22016 during surgery. The band 22002 and pad 22006 allow the visualization device to be securely positioned at the surgical site and allow the surgeon to operate and view real-time imaging of the surgery. Although in this embodiment, the visualization device 22000 images anatomical features located behind the ribs, the visualization device 22000 can be used in other applications to visualize anatomical features located behind or below other anatomical features, which typically obscure and hinder visualization of internal anatomical features. For example, hard tissue such as bone will prevent conventional ultrasound imaging from generating appropriate 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.

[0313] Fig.103B and Fig.103C FIG. 22000 is a visualization device 22000 fixed by a bracket 22052 and a bracket 22054 according to another embodiment of the present disclosure. The bracket may be Fig.103B Tripod 22052 as shown or Fig.103C Frame 22054 is shown having four legs. These supports are configured to simultaneously ensure secure attachment of the visualization device 22000 at the surgical site and provide access to perform a medical procedure.

[0314] According to another embodiment of the present disclosure, a transducer 23000 is Figure 104A-104D The transducer 23000 includes a central recess to receive a raised portion of the pad 23002, such as Fig.104A The transducer array is located on two surfaces 23004 of the central recess of the transducer 23000, as shown in FIG. Fig.104B The transducer arrays located on these inclined planes relative to the skin surface allow the wave transmission 23010 to focus and identify anatomical features. Fig.104C As shown, the anatomical feature in this example is a vein 23012. Once the transducer is coupled to the pad, the vein 23012 can be positioned to allow the raised portion of the pad 23002 to be directly over the vein 23012, such as Fig.104C The operator or inserter assembly can advance the needle 23012 into the raised portion of the pad 23002 along direction 23006 and precisely into the vein. This ensures that the needle does not inadvertently penetrate or damage other anatomical features such as the nerve 23012.

[0315] See now Fig.105, which shows a visualization device 25000 according to another embodiment of the present disclosure. As shown here, in this example, the visualization device 25000 is coupled to the brace 24000. The visualization device 25000 includes a mobile transducer array 25002 that moves on a 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 easy attachment to and removal from the brace 24000.

[0316] Figure 107A-107E 26000 according to another embodiment of the present disclosure. The visualization system 26000 includes a Fig.107A Multiple transducers 26001, 26002, 26003, 26004 at different locations as shown in FIG. Multiple individual transducers are located at different locations around the target surgical site. Fig.107A As shown, 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 the position of the transducer. 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. The operator can manipulate the image dataset to view specific features of the heart, such as Figure 107B-Figure 107D shown.

[0317] The visualization system 26000 allows the surgeon to view and analyze 3D, real-time images of the relevant anatomical parts on a remote screen 26005. Fig.107E As best shown, this allows the surgeon to perform surgery while viewing real-time 3D images of the anatomy generated by multiple transducers. Although cardiac surgery is shown in this example, the visualization system 26000 can be readily used for any medical procedure or specifically for imaging.

[0318] See also Figure 108A-C , which shows a kit 28000 according to another embodiment of the present disclosure. The kit 28000 may include a plurality of visualization devices 28100 ( Fig.108A ), these visualization devices 28100 can be combined with a plurality of pads 28200 ( Fig.108B) can be paired. The visualization devices 28100 can have different shapes, sizes, array configurations, displays, etc. In this example, three visualization devices 28100 are provided in the kit 28000: a small visualization device 28101, a medium visualization device 28102, and a large visualization device 28103. Similarly, the pad 28200 can have various configurations to pair with all or some of the visualization devices in the kit 28000. Fig.108B As shown, pads 28201, 28202, 28203, 28204, 28205, 28206, 28207, 28209, and 28210 have various shapes and configurations. Fig.108C As shown in , an operator can select a visualization device 28100 to be paired with a corresponding cushion 28200 from the kit 28000 for a particular visualization and / or procedure. The kit 28000 allows the operator to customize the visualization device and cushion based on patient-specific requirements.

[0319] Fig.108D A first example of a visualization device paired with a pad from kit 28000 to perform a specific image visualization is shown. Visualization device 28103 is paired with pad 28210, which has a concave surface to track the contour of the patient's abdomen in gynecological visualization. The visualized image (in this example, a baby) can be viewed and manipulated by an operator on visualization device 28103.

[0320] Fig.108E Another example of a kit 28000 is shown. In this example, a visualization device 28102 is paired with a pad 28208 and mounted on one side of a patient's knee to visualize the knee joint. In this example, the paired visualization device and pad can be secured to the patient's knee to allow imaging of the patient's knee during flexion and extension. The surgeon can visualize the knee joint in real time throughout the knee's range of motion to assess joint condition.

[0321] Fig.108F A third example of a kit 28000 is shown. In this example, a visualization device 28101 is paired with a pad 28206 to examine a patient's prostate. The compact size of the visualization device 28101 and the contoured shape of the pad 28206 allow the surgeon to conveniently place the assembly and perform visualization images without the need for invasive scanning. Another example of a kit 28000 is shown in FIG. Figure 108G 28000 to view the graft implanted in the fistula tract. The compact size of 28101 and the fixed placement of the components allow the surgeon to simultaneously view the 3D anatomy in real time and perform the procedure.

[0322] Figure 108H A table with technical specifications of various visualization devices according to an embodiment of the present disclosure is shown. Exemplary technical specifications of a small visualization device, a medium visualization device, and a large visualization device are listed in the table. The technical specifications include certain attributes of these devices, including size, battery requirements, and performance metrics. Figure 108H The values ​​shown in are exemplary and are not intended to limit the embodiments of the present disclosure.

[0323] See also Fig.109 , which shows a customized kit 29000 according to another embodiment of the present disclosure. A customized cushion 29200 is created and paired with a visualization device 28101. The cushion 29200 can be formed using a 3D printed mold 29002. The mold 29002 can be customized based on the patient's specific needs and the unique requirements of the operation. In this example, the surgeon uses a 3D printed mold 29002 to create a customized cushion. Fig.109 The tool 29203 shown performs a brachytherapy procedure.

[0324] Fig.110A -D shows 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. When the needle tip 30006 approaches the insertion point 30008, the sensor located on the visualization device tracks and displays the approaching needle tip on the visualization device 30002. Fig.110B As shown, 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 for precise access to the insertion point. Although a PMUT or CMUT transducer is provided on the underside of the visualization device 30002 to track the needle tip when it is below the visualization device - i.e., within the transducer range, other sensors such as cameras, infrared or near-infrared sensors may be provided to track the position of a needle that is adjacent but outside the projected coverage area of ​​the visualization device. In other embodiments, the PMUT or CMUT transducer may be disposed on an inclined surface to transmit signals outside the coverage area of ​​the visualization device to track and identify an approaching needle. The visualization device 30002 may provide various renderings and image enhancements to facilitate precise insertion. For example, a projection trajectory 30012 of the needle may be displayed based on the current position of the needle, such as Fig.110C This will allow the operator to adjust and align the needle to precisely enter the insertion point 30008. As the needle tip passes through the insertion point and enters the vein 30014, the vein and needle tip are displayed on the visualization device 30002, as shown in FIG. Fig.110D The visualization system provides 3D images with enhanced rendering in real time to ensure proper pre-alignment, insertion, and final placement of the needle.

[0325] Fig.116A visualization system 36000 is shown according to another embodiment of the present disclosure. The visualization system 3600 includes a visualization device 36002 that can be placed in a cushion 36004 via a slot 36008 provided in the cushion. The visualization assembly 36000 can be placed on a stool 36006 to allow imaging of a patient sitting on the stool. FIG17 shows a visualization system 37000 according to another embodiment of the present disclosure. The visualization system 37000 is similar to the visualization system 36000, but 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 furniture to facilitate imaging and / or surgery.

[0326] Fig.119A and Fig.119B 39000 according to another embodiment of the present disclosure. The visualization assembly 39000 includes a visualization device 39002 having a plurality of vents 39006, such as Fig.119A A fan or other pressure inducing element disposed within or connected to the visualization device 39002 pulls air through the vents, thereby creating a suction force. In addition, the air movement will promote cooling of the electronic components of the device and ensure proper function of the visualization device. The visualization device 39002 is coupled to the pad 39004.

[0327] Figure 122A-122D FIG. 4 shows a visualization device 42000 according to another embodiment of the present disclosure. Fig. 12A As shown, the visualization device 42000 includes a dual display window showing a plan view 42002 and a cross-sectional view 42004. If desired, the dual display can be disabled to show a single display. The operator can choose to view only the Fig.122D Plan view shown or Fig.122C The circular shape of the visualization device 122D allows the operator to easily grip and slide the device over the patient's skin to locate the appropriate insertion site. Once the site is identified, the operator can rotate the 3D image to further assess the anatomy of the potential insertion side, such as Fig.122C shown.

[0328] Fig.123A visualization device 43000 is shown in accordance with another embodiment of the present disclosure. The visualization device 43000 includes a camera or other sensor 43002 positioned on the outer side of the probe to identify and track the needle 43004. The display 43008 combines the vision of the anatomical features scanned by the PMUT or CMUT transducer with the real-time image of the advancing needle captured by the camera 43002. The visualization device 43000 allows needle tracking to determine the ideal needle angle and position before the needle subsequently enters the pad 43006 and insertion area.

[0329] See now Figure 127A-127D , which shows a visualization assembly 47000 according to another embodiment of the present disclosure. The visualization assembly 47000 includes a visualization device 47002 that can be coupled to a cushion 47004. The visualization device 47002 and the cushion 47004 are designed to be placed on the patient's face, skull, limbs, or body, such as Figure 127B-Figure 127D The skin contacting surface of the cushion 47004 may include various features to facilitate coupling with the patient's face, skull, limbs, or body. Fig.127A As shown, recesses 47004 are provided in the cushion 47004 to accommodate the patient's eyes. The visualization device 47002 includes a display 47008 that displays a 3D image of the brain 47010 in real time. Although the distal surface of the visualization device 47002 includes an array of transducers distributed throughout the face, only transducers that are not blocked by bone (i.e., the skull in this example) will be activated to transmit and receive signals. As shown in FIG. Fig.127C and Fig.127D As best shown in FIG. 4 , the active transducer 47018 propagates a signal 47012 that radiates 47014 and covers brain tissue far beyond the patient's eye. The active transducer transmits and receives signals between the gaps in the eye socket, such as Fig.127D 47000 is a 3D image of the brain. The brain is imaged in real time using a 3D image processing apparatus 47000. The brain is imaged in real time using a 3D image processing apparatus 47001. The brain is imaged in real time using a 3D image processing apparatus 47002. The brain is imaged in real time using a 3D image processing apparatus 47003. The brain is imaged in real time using a 3D image processing apparatus 47004. The brain is imaged in real time using a 3D image processing apparatus 47005. The brain is imaged in real time using a 3D image processing apparatus 47006. The brain is imaged in real time using a 3D image processing apparatus 47001. The brain is imaged in real time using a 3D image processing apparatus 47002. The brain is imaged in real time using a 3D image processing apparatus 47003. The brain is imaged in real time using

[0330] As shown here, 3D, real-time imaging can be performed using a transducer array with one or more independent arrays—that is, a continuous transducer array is not necessary. The processor of the visualization device 47002 determines the relative position and orientation of multiple transducers positioned on the patient's face, skull, limbs, or body to allow them to work together. 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 other arrays. The image formation and generation of each transducer array is similar to that of a single transducer array. Once this data is obtained, the processor can triangulate the array position and combine the data to generate a volumetric image data set. Therefore, the strategic activation of specific transducers and the ability to process the resulting image data set allow the visualization device to generate high-quality real-time image data of anatomical features located behind hard tissues (such as bones, body fluids, and other features that hinder imaging). In addition, the visualization device of the present disclosure can be placed in a single position to generate these images without the need to move the device around the surgical site.

[0331] As the number of arrays increases, more detailed images of the tissue of interest can be constructed. Image formation for each array is similar to the single array case, while triangulation between arrays can be used to combine data sets from multiple arrays.

[0332] The visualization device 47002 can include standard ultrasound signal processing that can determine the anatomical features of tissue in B-mode and tissue harmonic imaging. The visualization device 47002 can also use the Doppler effect to detect blood flow at the surgical site. The autocorrelation estimator in the visualization device can provide a display of combined spatial information and flow information in flow mode by using color to display information to the surgeon. Fourier analysis can be used to show the spectral distribution of Doppler shifts in pulsed Doppler and CW Doppler modes. The visualization device 47002 can also provide elastic imaging data that identifies tissue stiffness.

[0333] The visualization device 47002 may include quantified ultrasound ("QUS") to quantify the return echoes. The unique values ​​processed by QUS allow the visualization device to identify and distinguish various tissue types. For example, nerve and muscle tissue can be distinguished even though they appear very similar in a standard ultrasound display.

[0334] A QUS algorithm can be performed by a visualization device to estimate quantities such as the concentration of acoustic scatterers in the 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 measurements of the radio frequency signal applied to a beamformer from the visualization device. 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 quantities estimated by the QUS algorithm will reveal data that is encoded in the signal received by the visualization device but is not visible on a standard grayscale or color display. Different tissues have different values ​​for QUS parameters, which can be processed by a machine learning system to create and show the type of tissue present at each location in the imaging volume.

[0335] Fig.128A and Fig.128B 48000 according to another embodiment of the present disclosure. The visualization assembly 48000 includes a visualization device 48002 configured to be coupled to a cushion 48004. In one embodiment, the cushion 48004 may include a moldable material that acquires the shape of the visualization device 48002 when the visualization device 48002 is pressed onto the cushion, such as Fig.128B The visualization assembly 48000 is configured to be placed on the patient's eye to generate a monocular, such as Fig.128A . Display 48004 shows the eye scan in real time. In other embodiments, the visualization component can be customized for scanning various other body parts for pelvic imaging, abdominal imaging, transabdominal imaging, transrectal imaging, obstetric imaging, carotid artery imaging, abdominal aorta imaging, etc.

[0336] Move the needle

[0337] See above Figure 1A As discussed, for ease of reference, once 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, based on data provided by the navigation system, the inserter assembly can undergo small movements to ensure that the needle of the inserter assembly enters the patient at the puncture site and enters the puncture site at the appropriate angle, depth, and trajectory.

[0338] The housing function of moving the inserter assembly may be semi-autonomous or fully autonomous - for example, the housing may be capable of operating autonomously to move the needle to an optimal position and ready for insertion at the puncture site and to a desired position in the circulatory system (or other location in the skeleton or anatomy). The actual step of inserting the needle into the patient may then be performed autonomously (e.g., automatically inserting the needle into the patient once the optimal position is located) or semi-autonomously (e.g., by having an operator interact with the device via a button, etc. to initiate insertion).

[0339] In view of these functions, the housing may include various sensors, mechanical elements, etc., all of which increase the ultimate positioning of the needle at the puncture site.

[0340] For example, one embodiment of the present disclosure includes an insertion assembly 300 having a needle 301 in a housing 100, such as Figures 16A-16B As shown. Housing 100 includes a needle actuation system 150, which may include the above-mentioned elements such as sensors and mechanical elements (such as motors or servo mechanisms for precise control, positioning, insertion and extraction of the needle). For example, a servo motor can allow fine linear translation in all three directions, i.e., Fig. 16B The needle actuation system may also have a rotational joint or a pivot joint to allow the inserter assembly to rotate in one or more planes. This will allow the needle to be aligned along a predetermined insertion trajectory.

[0341] like Figure 16A-16B In the embodiment shown in FIG. 1 , the needle actuation system 150 is positioned within the housing 100 together with a sensor array 160, which may be part of a navigation system and / or may be a sensor that supplies information to the needle actuation system 150 to control the inserter assembly 300. The system 150 includes a master control arm 151 and the needle actuation system 150, the master control arm 151 connecting the inserter assembly 300 to the housing 100. The master control arm 151 is controlled by one or more servo mechanisms (not shown) also positioned within the housing 100. The direction and range of movement of the inserter assembly 300 are defined by the size of the inserter assembly and the size of the housing 100. Fig. 16B A top view of the housing 100 is shown to illustrate the range of movement of the inserter assembly 300 in the X and Y directions within the housing 100. In addition, the control arm 151 can 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 can provide adjustment of the angle of entry of the needle 301 at the puncture site and ultimately into the patient's blood vessel or other anatomical structure.

[0342] Figure 17A-17BShows something like Figure 16A-16B Another embodiment of the needle actuation system 150 is shown, except that in this embodiment, the inserter assembly 300 is flexible. As shown, the flexibility of the assembly 300 can allow for increased movement of the assembly 300 within the housing. Alternatively, the flexible assembly 300 can allow for the use of a smaller housing 100 while still maintaining the same Figure 16A-16B The flexible portion of inserter assembly 300 may simply be a flexible housing over the various elements of assembly 300, and / or may include flexible elements of assembly 300 such as tubes, vials, needles, etc.

[0343] In a specific embodiment, the device can provide a needle 301 that can be positioned in an infinite number of positions using a "universal" joint. Such a joint requires multiple servo mechanisms that can move the needle in any desired direction, including the X, Y and Z directions, the rotational direction, the T direction (i.e., the direction in which the needle is tilted), and the D direction (i.e., the direction in which the needle is driven) ("XYZRTD" movement). In this example, such universal movement may require a relatively large housing 100 to provide clearance for the inserter assembly 300 to move within the housing.

[0344] As described above, the navigation system can provide information to the needle actuation system 150 to guide the needle 301 to the correct position on the patient. In this way, the needle actuation system accumulates the data, and based on the data, the actuation servo mechanism moves the needle to the desired position as indicated by the navigation system. In addition, the servo mechanism can receive feedback through other sensors, which measure information such as the position of the needle and the inserter assembly 300, the force applied by the needle to the patient, the force of the patient's anatomical structure pushing back on the needle, etc. In this way, additional sensors such as force sensors or tactile sensors can be coupled to the needle actuation system to control and monitor appropriate needle insertion. Accurate servo mechanisms and motors ensure that the needle insertion motion is accurately executed to pierce the skin, etc. based on especially translation speed, penetration depth, penetration angle and insertion force. For example, the needle translation speed can be adjusted to reduce patient discomfort or increase the needle translation speed to achieve skin puncture. The needle actuation system can provide a variable needle translation speed, wherein the needle quickly pierces the skin (to reduce discomfort), and then decelerates to maximize accuracy while piercing the blood vessel. Similarly, the needle retraction speed may be variably controlled for optimized performance.

[0345] In one embodiment, the needle actuation system can be controlled by the operator as a semi-autonomous element. In such a configuration, a tactile force feedback system can be used. Specifically, a virtual tactile geometry of the needle insertion position, trajectory, and depth can be created to generate a virtual boundary that enables the operator to perform insertion with the aid of a navigation system and GUI. The needle actuation system can also include a micromanipulator coupled to a force sensor for precisely controlling needle motion in a semi-autonomous system.

[0346] Inserter assembly

[0347] The device can be configured for use with different inserter assemblies containing various needles and needle accessories. In one embodiment, once the needle is attached, the navigation sensor detects and calibrates the device to perform an insertion with the size of the attached needle. This will allow the device to be used universally with many different needles in different surgeries expected in typical hospital use. As described above, the desired needle can be included on the base prior to setup, or in some embodiments, the needle can be attached to the device once the base and housing have been positioned on the patient.

[0348] 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 and various accessories for use with the needles and positioned within the inserter assembly. For example, the inserter assembly may be a universal element that can be used with needles of any size and any needle accessories desired.

[0349] A solid needle (i.e., without a cannula) may be used with the present device, although a hollow needle may also be used to allow for flashback, whereby the operator can be assured that needle insertion into the vessel has been achieved. However, due to the feedback received from the navigation and needle insertion system, the present device may not require such visual confirmation to ensure that needle insertion has been successfully achieved. Thus, the device may function with a solid needle, which may reduce patient discomfort during needle insertion. Other needles may also be used with the present device, such as a flexible needle, an adjustable needle (e.g., a needle with a telescoping feature that allows the needle size to be minimized), etc. may also be used with the present device.

[0350] According to another embodiment of the present disclosure, Fig. 20A-B shows a kit containing a patch 750 with an inserter assembly 760. The inserter assembly 760 includes a skirt 762 positioned on the needle. The skirt can operate as an additional sterile shield around the inserted needle (and ultimately optionally a cannula) at the puncture site. The skirt includes an adhesive surface that fixes itself to the patient's skin at the puncture site, or the skirt can be combined with an integrated pre-applied patch 750, which is positioned on the patient's skin or can be positioned on the patient's skin. The patch 750 includes an upper layer 751 coupled to the device and the inserter assembly 760 and a bottom surface 754 for adhering to the patient's skin. The bottom surface 754 can be a self-sealing member that seals after the needle penetrates to prevent infection at the puncture site, and also keeps any blood from the puncture site away from the operator. The bottom surface 754 can include adhesive properties that can be activated or deactivated by the operator or any other response. Additional layers such as a flexible layer 752 having a vein preparation component to dilate an inserted vein are located between the bottom surface 754 and the upper layer 751. The vein preparation component may include heating agents, electrical agents, and chemical agents. Fig. 20A As shown, an analgesic layer 753 is also provided to reduce pain and discomfort during needle insertion. The bottom surface 754 can be secured to the skin via adhesion, light or vibration activated adhesion, friction, interlocking mechanisms, etc. This is particularly useful for long-term IV use, which typically requires additional tape to secure the cannula to the patient. Instead of the additional tape step, the operator can instead quickly slide the skirt into a position that helps clamp the needle / cannula in the proper position relative to the patient.

[0351] Specific reference Fig.28 31 , various exemplary embodiments are disclosed of how movement (including micro-motion) of the inserter assembly and / or housing may be achieved within any of the devices contemplated herein.

[0352] Figures 28 to 31C Various embodiments of the present disclosure are shown. As shown, the device 1200 includes a strut mounting structure or strut mounting member 1201, to which a plurality of articulated struts 1202 are mounted at a first end 1207 by an articulation joint 1203 such as a hinge, universal or ball joint, etc. The struts 1202 can provide linear motion driven by an integrated or adjacent linear motor 1204, such as a piezoelectric linear motor (such as a torsion motor), a pull wire with a remote motorized drive, or a pneumatic drive. The struts may alternatively include hinge portions. The advantages of these articulation and drive types are extreme miniaturization and accuracy. The strut mounting structure 1201 can be a full side hole or open side hole, having a plurality of articulated struts 1202, such as a piezoelectric linear motor (such as a torsion motor), a pull wire with a remote motorized drive, or a pneumatic drive. The struts may alternatively include hinge portions. The advantages of these articulation and drive types are extreme miniaturization and accuracy. The strut mounting structure 1201 can be a full side hole or an open side hole, having a plurality of articulated struts 1202, such as a piezoelectric linear motor (such as a torsion motor), a pull wire with a remote motorized drive, or a pneumatic drive. Fig.28 The roughly rectangular form shown in , or Fig.30the generally circular form shown, or Fig.31B and 31C The pillar mounting structure 1201 may include upright or angled pillars 1215, such as Fig. 31C As shown, the column 1215 is mounted from below or laterally to a pillar mount, such as a pillar mount that can be structurally connected to a housing, structure, frame, or integrated into an area of ​​the device 1200. Fig.31A and Fig.31B An embodiment is shown in which a strut mounting structure is integrated with a rigid aperture 1205 of the device 1200. The device may additionally include a floating platform 1210 to which a second end 1208 of each of the plurality of struts may be mounted, the floating platform having an articulation joint 1209 such as a hinge, universal or ball joint, or the like. In operation, the platform 1210 is positioned substantially adjacent to and / or parallel to the patient's body, for example at or near a target intravenous needle injection site. The plurality of struts may be mechanically articulated to enable the platform to move through up to 6 degrees of motion. Figures 28 to 31C In the illustrated embodiment, the device may have 6 struts 1202, commonly referred to as hexapods, which together are capable of moving the platform in all directions of X (lateral), Y (longitudinal), Z (into and away from the body), yaw (rotation), roll (sideways tilt), and pitch (forward and backward tilt). In alternative embodiments, the device may include 3 struts (referred to herein as a tripod) or 4 struts (referred to herein as a quadropod).

[0353] Continue to see Figures 28 to 31C , the floating platform 1210 may include an anatomical imaging module that is capable of acquiring 2D, 3D, or 4D data from a target site beneath the patient's skin. The platform is capable of moving with various degrees of motion to align with a preferred site. The platform may additionally move in a manner such that its underside presses into or massages an area of ​​the patient, for example to assess the properties of certain blood vessels under compression. This may provide important additional information in determining veins (as opposed to (typically less compressible) arteries). The platform may additionally vibrate or implement a tapping motion to stimulate the blood vessels to be more optimized, more dilated, or elevated closer to the skin surface for more cannulation conditions, i.e., to increase the size of the lumen and become an easier target. As Fig.29 and Fig.30 As shown, the platform and / or surrounding area may include a heating element 1211 to heat and promote dilation of the underlying blood vessels. Vibrations of the platform, such as by high frequency micro-movements generated by one of the plurality of struts 1201, may be activated upon needle insertion to act as a pain gate stimulus to confuse the local, adjacent, or surrounding peripheral nervous system by stimulating it. Fig.29As shown, the platform can include a cooling element 1212 that is targeted near or adjacent to the insertion site, which can be activated to induce a temporary anesthetic effect as a means of anestheticizing the sensory effects caused by needle incision, such as pain management.

[0354] In addition, the platform may include a fixed or articulated conduit 1213, which may also be referred to as a mounting, and may hold a needle or cannula, or an injection module 1214 that accommodates a needle and / or cannula. The conduit may provide additional degrees of motion relative to the platform 1210 (referred to herein as local motion) in addition to the degrees of motion provided by the plurality of struts 1202 (referred to herein as global motion). To a large extent, the conduit may provide 6 degrees of local motion, such as X yaw, Y yaw, Z yaw, R yaw, roll, pitch. More preferably, the conduit will provide local rotation (local yaw), local tilt (local pitch). Further motion provided by the platform mounted conduit 1213 or within the injection module or cannula itself (referred to herein as super-local motion) may include actuation (to push or pull the needle or cannula along its own axis) and twisting (to rotate the needle or cannula around its own longitudinal axis). In some embodiments, the conduit 1213 and injection module 1214 may be provided as a component.

[0355] Once the device 1200 has lined a target vessel guided by its imager module, if the target subsequently moves, for example due to patient or operator jitter or tremor, or the device otherwise moves away from the target, the device can automatically correct the position and trajectory of the needle held by the tubing to keep the target in line, hence the term floating platform.

[0356] In addition, the device 1200 with an integrated strut mounting structure is preferably configured to be compact in external dimensions while also providing a maximum range of motion to the floating platform therein so as to provide the ability to scan relatively large areas of the anatomy so that optimal needle or cannula insertion conditions can be found. The height of the entire device 1200 may be between and including 8 mm and 22 mm. Fig.29 The circular embodiment may have a diameter between and including 25 mm and 75 mm. The platform 1210 may be mechanically lockable so that the user can move the device around the arm as an initial positioning step, and thereafter the device with the integrated floating imaging platform may perform finer or minute degrees of motion and image and needle alignment.

[0357] In addition, the device 1200 may include a control unit and a display. The display may be substantially the same size as the top surface of the device and may include touch controls. The device may alternatively or additionally include a controller bar or joystick. The operator may use these controls to operate any or all of the mechanized degrees of motion to use robotic assistance to align and place a needle or cannula.

[0358] Figure 86A-Figure 89C An inserter assembly 18000 is shown according to another embodiment of the present disclosure. The inserter assembly 18000 includes a three-degree-of-freedom parallel mechanism that positions a needle drive mechanism 18001. The needle drive mechanism 18001 carries and moves a needle 18020 to perform the insertion. A single-degree-of-freedom mechanism drives the needle driver 18008 into the patient's anatomy and retracts the needle when the procedure is complete. Fig.86A As best shown in , inserter assembly 18000 can be attached to device 5000 and pad 16000 .

[0359] The needle 18020 is mounted on the lead screw 18017 and the threaded carriage 18016, as shown Fig.89C As shown. The carriage 18016 is constrained 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.

[0360] The needle 18020 can be contained in a single-use sterile container, through which the movement is controlled while maintaining a sterile barrier between the mechanism and the needle.

[0361] Two parallel linear mechanisms (such as the lead screw 18006 shown here) jointly control the angle and position along the x-axis of the main carriage 18012 to control the needle insertion position. The linear mechanism is coupled to the main carriage 18012 in such a way that the main carriage 18012 will maintain a constant orientation and move along the x-axis when moving synchronously. In addition, the coupling between the linear mechanism and the main carriage 18012 allows the main carriage to rotate with zero translation when moving 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 can rotate freely relative to one pin and rotate and translate freely relative to another pin. In an alternative embodiment, the function of the pin and the main carriage can be combined by a compliant structure comprising a flexure hinge and a threaded feature engaged with the lead screw.

[0362] Two support shafts 18011 are provided to prevent moments and loads on the needle that are not aligned with the x-axis. This improves efficiency and extends the service life of the linear mechanism 18006.

[0363] The linear guide 18007 is the interface between the needle driver and the main carriage 18012, allowing free movement along the y-axis while constraining movement in other directions. The track 18004 controls the Y position of the needle driver 18008 while allowing unconstrained movement of the needle driver along the x-direction. The connecting pin 18019 engages between the track 18007 and the needle driver 18013.

[0364] A linear mechanism 18001, such as a lead screw as shown here, controls the movement of the track 18004 along the Y direction. Two linear guides 18003 prevent torque from being applied to the track, thereby increasing the efficiency of the linear mechanism 18001 and extending its service life.

[0365] 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 may 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, but the linear mechanism 18009 may directly prevent off-axis loads. This is advantageous because it makes the mechanism more compact.

[0366] By using a lead screw for all four axes, the linear resolution of the inserter assembly 18000 is significantly increased, so that for a full rotation of the motor, the needle can move a small portion of the vein diameter. In addition, the effect of the backlash in the motor is significantly reduced. Unexpected overloads on the device due to operator error or accident will not be transmitted to the motor due to the non-reverse drive ability of the lead screw and the gear coupling between the motor and the lead screw. The positioning and insertion speed of the inserter assembly 18000 are in the same order of magnitude as a human operator. In addition, the inserter assembly 18000 is configured to apply a force similar to that of a human operator to insert and manipulate the needle into the human anatomical structure.

[0367] Figure 93A-93F 19000 according to another embodiment of the present disclosure. The inserter assembly 19000 includes two components 19005 that can move in opposite directions to produce a rotation of the linear mechanism 19004 and control the angle p of the needle drive mechanism, as shown in FIG. Fig.90 A member 19005 is coupled to the linear mechanism by a pin joint 90012 which can rotate relative to the member and translate relative to the linear mechanism.

[0368] Component 19005 can be controlled by a gearbox that links the two components so that their movement in the X direction is opposite to each other and is driven by a single gear. The gearbox can rotate the components around axis P to affect the rotation of the linear mechanism around axis P and the movement of the needle axis mainly in the Y direction.

[0369] The gearbox is driven by two worm gears 19011 which can independently control the rotation of the gearbox and the movement of the linkage. The movement of the linkage is controlled by a rack and pinion 19015, where power is transmitted through a central shaft driven by a large sun gear 19013. The linear mechanism 19004 controls the position of the main carriage 19007 primarily in the X direction. The main carriage 19007 is moved by a linear mechanism that carries a linear actuator such as Figure 93D-Figure 93F Needle drive mounting 19009 is best shown in FIG.

[0370] The linear mechanism may include a lead screw 19017 that drives the carriage. A needle driver mount 19009 to which the needle driver is attached is attached before the procedure begins. 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 affects the rotation of the needle driver, thereby controlling the angle φ, as Fig.91 shown.

[0371] Five electromagnetic rotary motors 19002, 19003, 19010, 19019, 19020 can be used to power the inserter assembly 19000 due to their high power density. Power can be transmitted through the shaft to the linear mechanism that drives the needle. Torque can be transmitted to the lead screw through the mating pin 19019, and the user can temporarily secure the housing to the inserter assembly 19000 through a push and twist motion. The cartridge can be a single-use, sterile, non-powered, self-contained assembly.

[0372] The mechanical design of the arm 19005 linkage and the differential gearbox in the inserter assembly 19000 is particularly advantageous because it allows highly accurate and independent control of both the ф orientation and the ρ orientation of the main slide 19007 from a remote location.

[0373] Figure 94-96An inserter assembly 20000 according to another embodiment of the present disclosure is shown. 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 drive the needle into the patient's anatomical structure. 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 converts the rotational motion of the cam driver 20004 about the axis A into the rotational motion of the needle guide about the axis B, as shown in FIG. Fig.94 and Fig.96 Best shown.

[0374] Two rotary actuators 20002 drive the mechanism to translate the needle 20003. The actuators 20002 can be electromagnetic, piezoelectric, pneumatic or hydraulic motors. A cam driver 20004 coupled to one of the rotary actuators contains a feature that is received by the cylindrical slot 20010 but is free to rotate within the cylindrical slot. In one embodiment, this feature can be spherical.

[0375] A pivot pin 20005 coupled to one of the rotary actuators controls rotation of the needle guide feature 20001 about axis A. The pivot pin 20005 is coupled to the needle guide feature to ensure that rotation of the needle guide about axis B is substantially unconstrained.

[0376] In one embodiment, for the purpose of compactness of design and further mechanical advantage, the rotational motion is transmitted from the rotary actuator 20002 through intermediate gears 20007, 20008, 20009 to the cam driver 20004 and the pivot pin 20005, as shown in Fig.96 In other embodiments, the rotary actuator can be coupled directly to the cam driver and pivot pin or through a worm gear to allow the inserter assembly 20000 to fit within different enclosures or for the purpose of increasing the force and / or speed of needle insertion.

[0377] The inserter assembly 20000 is particularly easy to miniaturize due to the similar scale of the motor and mechanical parts. The fixed motor of the inserter assembly 20000 has a reduced inertial mass. The mechanism of the inserter assembly 20000 rotates the needle about two independent perpendicular axes A and B, thereby allowing the angles φ and ρ to be controlled separately, as shown in FIG. Fig.94 and Fig.96 This allows rotation about axis A to be driven directly by the rotary actuator, and rotation about axis B to be driven indirectly by the cam follower.

[0378] Now refer to Figure 97-Figure 100, which shows an inserter assembly 21000 according to another embodiment of the present disclosure. The inserter assembly 21000 includes three linkage mechanisms 21001, 21002, 21003, which together control the position and orientation of the linear mechanism 21004. In one embodiment, the linkage mechanisms 21001, 21002, 21003 each have a Fig.99 The single degree of freedom of motion in the y direction shown. Each of these linkages is driven by an independent linear actuator. The control of the angle ф is basically achieved by the relative movement of the linkage 21002 and the linkage 21003. The control of the angle ρ is basically achieved by the relative movement of the linkage 21001 and the linkage 21002 or the linkage 21003.

[0379] Each linkage is coupled to the linear mechanism via a joint with a 2-DOF pivot, such as a ball joint. The linkage 21002 includes an additional 1-DOF joint 21010 to prevent binding during rotation ф.

[0380] The linear mechanism 21004 includes an actuator to drive the carriage 21005 substantially in the X direction. An actuator 21009 mounted to the carriage 21004 transmits torque to the needle driver 21006 through the needle mounting interface 21008 to power the insertion and retraction of the needle 21012 into the patient's anatomy.

[0381] The needle driver 21006 can drive the needle into and out of the patient's anatomical structure. In one embodiment, the movement can be controlled by a lead screw. The needle driver can be single-use, sterile, and assembled to protect the healthcare provider and the patient from pathogen contamination. The housing 21007 can contain an actuator that provides power to the linkage. The housing can secure the inserter assembly 21007 to prevent undesirable movement during surgery.

[0382] The inserter assembly 21000 provides full control over the position and orientation of the needle with 4 degrees of freedom, allowing complex entry trajectories. When the single-use / sterile syringe is not installed, the inserter assembly 21000 collapses to a small volume relative to the length, width, and depth of the working space it can access, such as Fig.100 The inserter assembly 21000 can accommodate needles of various lengths, gauges, and configurations, and can provide resistance to breakage in all five axes of motion by using a non-backdrivable leadscrew.

[0383] Fig.118A and Fig.118BAn inserter assembly 38000 is shown according to another embodiment of the present disclosure. The inserter assembly 38000 includes a foldable frame 38002 that can hold a needle 38006. The inclination of the foldable frame can be adjusted to adjust the entry angle of the needle 38006. The needle holder 38004 on the swivel allows further adjustment of the needle entry angle. After determining the precise insertion position and needle angle trajectory, the needle can be manually advanced or retracted. The inserter assembly 38008 includes an adhesive surface 38008 to securely secure the inert assembly at the target surgical site, such as Fig.118B Best shown.

[0384] Fig.121 An inserter assembly 41000 according to another embodiment of the present disclosure is shown. The inserter assembly 41000 includes a barrel 41002 containing a needle. The barrel 41002 can be placed in a frame 41005, which is mounted on the surgical site via a brace 41006. The frame 41006 allows movement in three axes to position the needle at the optimal insertion point. The frame 41006 can be made of a transparent material 41004 to provide the operator with a clear view of the insertion. The barrel 41002 can be a reusable barrel that can be easily replaced at each insertion.

[0385] Now refer to Fig.126 , which shows an inserter assembly 46000 according to another embodiment of the present disclosure. The inserter assembly 46000 can be secured to a belt 46004. A needle 46008 can be loaded into a loading chamber and activated by a button 46002 to perform a 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 that the needle entry is at the insertion point 46010. The insertion point can be highlighted by a laser crosshair or other indicator to assist the operator.

[0386] Commonly used methods

[0387] A method of performing a semi-autonomous needle insertion using the device 10 will now be described. The puncture site skin area for insertion is prepared by manually wiping or sterilizing the area or by applying a protective mask. The mask may also include an ultrasound-compliant hydrogel to facilitate ultrasound scanning, thereby eliminating the need for manual application of ultrasound gel. After preparing the skin area, the user may dock the housing 100 to the base 200 and place the assembly on the puncture site area. A belt or other fixing element may be used to fix the device to the patient. However, the fixing belt in this embodiment will have sufficient slack to allow the operator to move the base through the puncture site area to scan the patient's blood vessels. 3D scanning using any of the techniques described herein may be used to generate a 3D map of the patient's blood vessels. The 3D map may include real-time images and / or static images, such that, for example, an area directly in the view of the 3D sensor may be shown in real time, and other areas that are not in the line of the 3D sensor may be scanned and saved to generate a 3D map of the patient's blood vessels. The GUI on the device 10 may project a 3D map of the puncture site on a display screen located on the housing 100, or transmit the data to another monitor located away from the device 10. The device 10 may include a puncture site reference marker that can help the operator accurately position the device over the puncture site by aligning the puncture site reference marker with the blood vessel of the 3D map. Once the device is successfully positioned over the puncture site, the operator can activate the insertion mechanism to insert the needle into the puncture site along a predetermined trajectory. After the needle insertion is established, the housing 100 can be removed from the base without interfering with the needle, leaving the needle assembly fixed to the patient through the base.

[0388] A method for performing autonomous needle insertion using the device 20 will now be described. The puncture site skin area for insertion is prepared by manually wiping or sterilizing the area or by attaching the device 20 to the puncture site skin surface. The device 20 may include disinfection features such as ultraviolet light or other disinfectants. Alternatively, a protective mask may be first placed on the puncture site surface, and the device 20 may be mounted on the mask. As described above, the mask may include various features such as ultrasound compliant hydrogel to facilitate ultrasound scanning, thereby eliminating the need for manual application of ultrasound gel. After preparing the skin area, the user may dock the housing 400 to the base 500 and place the assembly on the puncture site area. By docking the housing 400 to the base 500, the plate 550 may be removed from the device 20 because the inserter assembly 600 is now fixed by the housing 400. The band 508 may be used to secure the device to the patient's skin. The operator may then initiate a 3D scan through the GUI, whereupon the device scans the patient's blood vessels and draws a 3D map. The 3D map may include real-time images and / or static images, where, for example, the area directly in the line of the 3D sensor can be shown in real time, and other areas not under the line of the 3D sensor can be scanned and saved to generate a 3D map of the patient's blood vessels. The GUI on the device 20 can project the 3D map of the puncture site on a display screen located on the housing 400, or transmit the data to another monitor located away from the device 20. The device 20 may include a puncture site reference mark, which can help the operator accurately position the device on the puncture site by aligning the puncture site reference mark with the blood vessel of the 3D map. Once the device successfully identifies the puncture site insertion site and determines the trajectory for achieving insertion, the operator can activate the insertion mechanism to insert the needle into the puncture site along a predetermined path. The operator can be located away from the device and can remotely activate the insertion mechanism. Alternatively, the device can be completely autonomous, whereby the device automatically activates the insertion after identifying the puncture site with little or no operator input. When the needle is inserted, the housing 400 can be removed from the base without interfering with the needle, leaving the needle assembly fixed to the patient by the base.

[0389] In other approaches, once the appropriate puncture site, insertion trajectory, and target vein have been identified, the operator may then use this information to select and attach a needle to the device for subsequent insertion of the needle at the puncture site.

[0390] Automation level

[0391] As described above, the device can be semi-autonomous or fully autonomous. Individual components such as navigation systems, displays and user interfaces, and inserter assemblies can 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 locate 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 only attach navigation and sterilization components to the housing to perform specific functions. This will allow the housing to be used over a wide range of applications by being customizable to each of these applications.

[0392] Additional Design

[0393] Fig.18 and Fig.19 Various embodiments of patches are shown that can operate as both a pre-injection patch and a base as described above. Fig.18 As shown, patch 950 can be applied to the area of ​​the patient where the puncture site is desired. Patch 960 can be wrapped around the patient's skin, such as Fig.19 The housing may then be engaged with the patch, as described above. Such a patch may be particularly useful, for example, where the housing includes ultrasound navigation functionality, whereby the patch would include a hydrogel or other such ultrasound conductive layer. The patches of these embodiments are also useful because the housing can be freely moved around the surface of the sterile patch without worrying about moving the housing outside the sterile field.

[0394] Another exemplary embodiment of a gel-based pad that may be used as part of the apparatus of the present disclosure is described below.

[0395] Figure 81A-Figure 81C An embodiment of a pad 15000 is shown. Pad 15000 is a flexible, 3D, device-integrated, xerogel coupling agent that improves ease of use by promoting consistent transmission of ultrasound waves and simplifying transitions between the organic and deformable human forms and the rigid and exemplary device 5000 shown herein.

[0396] Currently, a viscous liquid gel is required as a coupling agent to create a transition between an ultrasound ("US") probe and the patient's body to successfully carry ultrasound waves back and forth. The gel is messy, cumbersome, and unhygienic. Utilizing a flexible formed 'dry gel' (sometimes called a hydrogel), these pain points can be eliminated. The additional 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.

[0397] One of the main challenges that this solution addresses is the mismatch between the organic and variable nature of the human body and the rigid and finite shape of the US probe. The transition or coupling between these two different surfaces is very difficult to overcome with wet gels or even the current dry gel products currently available. The operation still requires good refinement from the operator to achieve quality images.

[0398] The size, thickness, density, consistency, flexibility, material and surface treatment enable the pad 15000 to easily and effortlessly couple the device 5000 to any part of the body, large or small, such as Fig.81B and Fig.81C The cavity 15002 is shaped to easily receive the CMUT array 5004 .

[0399] The pad 15000 promotes easy engagement with the patient's body. The CMUT array 5004 is designed and engineered to have high quality data capture. Any layer, material, form, or production process added to the probe face to improve engagement with the human body can be de-prioritized because the pad 15000 meets these requirements.

[0400] Further, the pads 15000 may be customized or provided in standard sizes, rather than a one size fits all approach for use in the U.S. For example, a set of pads 150000 may be used to improve coupling for specific conditions ranging from newborns to the elderly, rather than the obese.

[0401] The pad 15000 can be made of a highly flexible but solid transparent material that fits tightly onto and seamlessly integrates with the device 5000 and enables coupling anywhere on the body to easily place the device and contact the skin. Small movements and pressure changes are easily absorbed by the xerogel while capturing clear and precise images on the display 5012. Curvatures and inconsistencies on the surface of the patient's body are easily overcome by the flexibility of the pad 15000.

[0402] Figure 82A-D A pad 16000 is shown in accordance with another embodiment of the present disclosure. Pad 16000 is substantially similar to pad 15000, but includes a distal surface that is contoured to any surface features. Figure 82B-Figure 82D As shown, the distal surface of the pad 16000 conforms to the corresponding surface to form a secure attachment.

[0403] Now refer to Figure 83A-Figure 83I , which show various embodiments of pads 15000 according to the present disclosure. The pads 15000 shown in these figures include various designs and shaped 3D xerogel forms that enable three-dimensional CMUT (US) configurations and surfaces for improved data capture and ease of use.

[0404] Freed from the ergonomic constraints of direct engagement with the patient's body, the CMUT array 5004 of the exemplary device 5000 can be fully optimized for data capture for intravenous access or other procedures. The pad 15000 can be provided in a variety of forms and configurations to capture all the necessary details of intravenous access. For example, Fig.83A The pad 15000 is shown in a flat rectangular shape.

[0405] A completely flat array may not be an ideal configuration for venous access. Veins are superficial, small, and often mobile. The curvature, 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 A pad 15000 is shown having a tapered distal end with a larger display 5012. Fig.83C The pad 15000 is shown with a distal end that flares out from the display 5012, resulting in a pad with a larger contact surface. Fig.83C A smaller screen 5012 is used in the embodiment shown in FIG. 5 , thereby enabling a smaller and more compact device 5000 .

[0406] Fig.83D A pad 15000 is shown that can be coupled to a CMUT array 5004 having one or more openings. The CMUT array 5004 has a single opening 15005 that allows a needle to pass through. Fig.83D As shown, opening 15005 is filled by gasket 15000. Fig.83E A similar CMUT array 5004 is shown, where the two arrays are tilted on either side of the opening. In other embodiments, various different configurations of the CMUT arrays can be accommodated by the gasket 15000. For example, Fig.83F A stepped CMUT array 5004 is shown, and Figure 83G A concave CMUT array 5004 is shown. In yet another embodiment, Figure 83H As shown, the pad 15000 can be concave or convex, and as shown Figure 83I The illustrated pad 15000 may be flexible.

[0407] Fig.84A pad 17000 is shown 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 through the device 5000 and view it via the display 5012, while observing the insertion site 17007 with the naked eye through the clear gel of the pad 17000. Since the device itself would typically block the operator's view of the insertion site, the operator must slide the device to slide through the insertion area. The pad 17000 will enable a simulated view of the site from above, while also providing a subsurface view (US) of the insertion site on the display 5012. The pad 17000 enables the device 5000 to be recessed backward from the insertion site, as shown by the angled CMUT array 5004'. Fig.84 shown.

[0408] Figure 85A-Figure 85C The insertion process of different embodiments using gel pads is shown. Fig.85A Before the thin, low-profile pad 15000 shown in FIG. 5 is inserted, the needle tip 5010 cannot be viewed in the display 5012. The thin, low-profile pad contacts the needle during or just before insertion, so the needle cannot be viewed with the display 5012 before insertion.

[0409] Fig.85B The thicker liner 15000 shown allows the needle tip 5010 to enter the liner 15000' prior to insertion into the patient. Thus, the needle tip 5010 can be tracked prior to insertion. Fig.85B As shown, the thickness of the liner 15000' must take into account the size of the needle, the needle entry angle, and the distance of the insertion area from the edge of the liner 15000'.

[0410] Fig.85C Needle insertion utilizing the above-described pad 17000 is shown. As shown here, the angled shape of the pad 17000 allows the needle to enter the pad before reaching the insertion point. Thus, the needle tip 5010 can be viewed on the display 5012 before the needle actually pierces the patient's skin. In addition, the clear nature of the gel used in the pad 17000 allows the operator to view the insertion site and track the needle tip directly through the clear gel. As the needle is placed into the gel, the CMUT array collects data about the position of the needle and incorporates that data into the image on the screen. Any adjustments that may be needed to the needle trajectory, the position of the pad (and imaging device), etc. can be made before piercing the skin, but the needle remains in the pad and is viewable by the naked eye or on a display. Thus, the pad 17000 conveniently allows imaging and surgery to occur simultaneously.

[0411] Fig.111A and Fig.111B31000 according to another embodiment of the present disclosure is shown. The liner 31000 includes a recess 31002 configured to seat and align a needle 31004 to facilitate accurate insertion. Fig.111A As shown in the liner, the liner 31000 can be coupled to the visualization device 31003.

[0412] Now refer to Fig.112A and Fig.112B , which shows a liner 32000 according to another embodiment of the present disclosure. The liner 32000 includes a flexible port 32004 to receive and align the needle 32004 to facilitate accurate insertion. Fig.112A As shown, visualization device 32003 can be coupled to pad 32000. In other embodiments, various types of recesses, ports, and other receptacles can be included or integrated into the pad to receive, hold, and align the needle.

[0413] Fig.113 33000 according to another embodiment of the present disclosure. The liner 33000 includes a self-sealing slit 33003 that can receive a visualization device 33002. Fig.113 As shown in , the cushion 33000 is configured to completely enclose and protect the visualization device. The cushion 33000 can be made of a transparent gel to enable an operator to view and utilize the visualization device 33002 placed within the cushion. In some embodiments, the cushion 33000 can include a split body attached by a hinge 33004 to allow access to the embedded visualization device.

[0414] See now Fig.114A , which shows a pad 34000 according to another embodiment of the present disclosure. The pad 34000 includes a gel layer 34004 and a skin contact adhesive layer 34002. 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 shifting in accordance with the advancing needle pressure ( Fig.114B ) and prevents the vein from shifting in response to advancing needle pressure ( Fig.114C ).

[0415] Figure 115A-C A pad 35000 is shown in accordance with another embodiment of the present disclosure. The pad 35000 includes a pair of ridges 35002 that can be positioned on either side of a vein 35004 to stabilize the vein and prevent it from rolling up under approaching needle pressure.

[0416] The pads can be configured to perform a wide variety of functions. For example, the pads can be customized to prevent infection, protect skin health, secure components of a device, reduce pain, optimize veins or other anatomical features, and the like.

[0417] In one embodiment, the pad may include a low friction hydrogel device cover. The low friction hydrogel device cover will enable the device to be smoothly and steadily guided across the skin surface with little effort by the operator.

[0418] In another embodiment, the pad can be configured as a large-format stable pad that is highly adaptable to easily transition from a flat sensor surface to the unique contours of a patient's body. The pad can be independently fixed directly to a desired surgical area (such as a patient's chest or abdomen) to ensure that the distal side surface of the pad contacts the body. A device with a large-format imager module can be coupled to the proximal surface of the pad. The transducers on the large-format imager module are positioned to capture and display volumetric data of the surgical site. For example, the transducers of the large-format imager module are distributed on the imager module to capture volumetric data of the chest cavity and heart through an opening between the ribs using a single read—that is, without having to slide or move over the target site to generate image volume data. Alternatively, strategically placing the transducers in specific locations on the imager module can generate volumetric data using a single read to capture image volume data.

[0419] In another embodiment, the pads can be customized to fit a specific body part for a specific examination and / or procedure, thereby ensuring convenient imaging of areas with difficult accessibility. The need for invasive scans is also reduced by these customized pads. In addition, the body part specific pads require less operator training and specialization to utilize these pads. The body part specific pads can be paired with equipment and imager modules to create a kit for a specific examination and / or procedure. Fixation devices can be customized for these pads to secure the body part specific pads.

[0420] According to another embodiment of the present disclosure, the cushion can be designed as a patient-specific cushion. A customized cushion for each patient can be generated based on the patient's unique individual attributes before an examination and / or surgery.

[0421] In one embodiment, the pad can include various infection prevention properties. A pad according to this embodiment can include an antimicrobial layer to prevent infection of the target site. The pad can be made of a clear gel to provide a clear view of the target site and allow the needle to pass directly through the pad.

[0422] In one embodiment, a kit may include at least one pad and at least one device. For example, such a kit may include multiple pads and one device, whereby the pads are sized and shaped to be used with a specific device. In addition, each pad may have a shape that is different from at least one other pad, so that each pad may be specific to a specific operation and / or anatomical location, while all pads may be used with a specific device. In another example, such a kit may include multiple pads and multiple devices, whereby the size and shape of each pad is designed to be used with at least one device. A user of the exemplary kit may select a desired pad and device combination for use in a specific operation and / or anatomical location.

[0423] In another embodiment, a method of using a device may include selecting a specific pad and a specific device, and using the combined pad and device to view an anatomical location of a patient. Such a method may also include using a pad and device with a combination of one or more medical devices or instruments to view an anatomical location of a patient and to view (one or more) medical devices and / or (one or more) instruments near the anatomical location. This method may also include using a combined pad and device, or different combinations of pads and devices to view more than one anatomical location. In one example, a first combination of pads and devices may be used to view visualization of a catheter inserted into a patient, and once the catheter enters the abdominal or thoracic vasculature, a different combination of pads and devices may be used.

[0424] Fig.120A -D shows a vein dilator 40000 according to another embodiment of the present disclosure. The vein dilator includes a needle 40008 that can be translated by a grip 40004. A skirt 40006 surrounds the needle and forms a seal with the patient's skin, such as Fig.120B Once the needle has been inserted into the collapsed vein 40010 ( Fig.120C ), the balloon member 40002 can be squeezed to push air through the needle and into the collapsed vein 40010 to dilate the vein, such as Fig.120D shown.

[0425] Fig.124 A sterile adhesive 44000 is shown according to another embodiment of the present disclosure. The sterile adhesive 44000 provides a sterile area through which a needle can be inserted. No additional sterilization is required when using a sterile adhesive. Various features can be added to the sterile adhesive to assist in needle insertion. For example, a target marker 44302 can act as an alignment and positioning guide for needle insertion.

[0426] Fig.125A and Fig.125BFIG. 4 shows 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. Fig.125B As shown, the distal tip of needle 45000 can be altered from puncture point 45002 to allow smooth entry into the vein to a flat surface 45004 to ensure that the needle does not pass through the vein.

[0427] closed loop

[0428] In another embodiment, an automated or semi-automated mechanized intravenous needle positioning device or system can perform multiple output functions to optimize anatomical targets, or other conditions associated with intravenous needle placement such as reducing pain, assisting the mechanized positioning of imagers or insertion modules. The measurement of various device outputs can be achieved by ultrasonic imaging transducers such as CMUT or camera sensors, NIR or other imaging systems, and monitor changes in 2D or 3D data maps of target anatomical structures or temperature sensors. Other monitoring methods can include reading the patient's local or central body temperature, hydration level, heart rate, blood pressure, sweat level, general or sudden movement, shaking and tremor, noise and distress level (some or all of these can also be monitored on the operator (e.g., 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 can be fed back to the operator, or input to the electrical or electronic control system of the device or system, so that adjustments to the device output can be performed, and / or programming is performed when more optimized input readings or conditions are met. The feedback or closed-loop system is designed to automatically achieve and maintain desired output conditions by comparing the desired output conditions to actual conditions in real time.

[0429] Continuing with this embodiment, there are various examples of: mechanical or electrical stimulation performed to induce a functional response in a patient's organ, vessel, tissue, or extremity or central nervous system, or to guide a mechanical imager or needle positioning device within the system. Examples may include stimulation to optimize properties of a target vessel or anatomical structure (such as venous dilation or stability) by automatically tightening an integrated tourniquet; applying heat to a target area injection site, such as to increase venous dilation, by an integrated heating element; applying mechanical vibration or tapping, for example, to stimulate a target vessel; inducing mechanical pressure or a similar massage effect at or around a target injection site to measure vascular properties under compression or stimulation (veins are generally more compressible than arteries, or weak or thin veins may roll or move more than healthy veins). These inputs can typically be performed by a human operator in normal practice, but are time consuming, highly manual, and require patience and skill to perform effectively.

[0430] In another example, a venodilator or analgesic is automatically released into the body around the target insertion site, or local cooling is applied at the insertion site, or a similar anesthetic technique. This would typically be performed manually, and adds unnecessary additional manual preparation and time before the operation. The effectiveness of these outputs can be monitored in real time by outputting and then monitoring the physical stimulation of the patient, i.e., inducing and then measuring changes in the nervous system response (i.e., pain relief or distraction work), or simply asking the patient (in which case the determination of the patient's pain sensation can be input to the device or system). Input feedback to the automatic system can be to increase or decrease analgesic titration or cooling or similar output, or to implement distraction methods at the time of injection, such as induced response, as further discussed below. Or delay the process until more optimal conditions are met.

[0431] In another example showing fluid control, pushing fluid or therapy into the body or drawing blood from the body can usually be performed manually by an operator or an external infusion pump or system. The contemplated device can mechanically assist such fluid control semi-automatically or fully automatically. The effectiveness of these mechanical outputs can be monitored in real time by sensory monitoring of vascular expansion or collapse, fluid flow rate, obstructions, needles or fluid rupture of blood vessels (e.g., using ultrasonic transducers and 2D or 3D or 4D anatomical data mapping). Input feedback sent back to the automated system can cause the fluid flow rate to increase or decrease or stop completely.

[0432] In another example, to induce a response from the patient so as to distract from injection pain or other physical input, the device or system and / or its operator can induce a physical response from the patient, such as triggering a rapid expulsion of air from the lungs (to induce or ask the patient to cough), or emitting or making rapid physical movements or sounds on demand (such as clapping or hitting an object), or interacting with an instant stimulation device or prop (such as a doll box, for example). Or alternatively, the system can communicate and work in conjunction with an external stimulus (such as an audio system or other device attached to or held near the patient), which when activated can capture the patient's attention, perhaps in surprise, or a slight shock, such as with a temporarily elevated blood pressure heart rate. The induced physical actions can be monitored by integrated or external sensors, allowing input information to be looped back to the control system, for example, so that the peak moment of pain (i.e., at the time of needle injection) can be scheduled with peak physiological distraction.

[0433] In addition, although the invention disclosed herein has been described with reference to specific features, it should be understood that these features are merely illustrative of the principles and applications of the present invention. Therefore, it should be understood that many modifications (including changes in the dimensions of the various features described herein) may be made to the illustrative embodiments and other arrangements that may be designed without departing from the spirit and scope of the present invention. In this regard, in addition to those specific features set forth in the following paragraphs, the present invention also includes many additional features. In addition, the above disclosure should be understood by way of illustration rather than by way of limitation, because the present invention is defined in the examples of numbered paragraphs, which describe the features set forth in the following claims according to various embodiments of the present invention.

Claims

1. A method for performing medical imaging using a plurality of imagers, the method comprising the following steps: placing a first imager at a first position relative to the anatomical site; placing a second imager at a second position relative to the anatomical site, wherein the first imager and the second imager are configured to be positioned independently of each other; generating a first volumetric image dataset using the first imager; generating a second volumetric image data set using the second imager; and combining the first volumetric image dataset with the second volumetric image dataset to generate a third volumetric imaging dataset of the anatomical region; Therein, the third volumetric imaging dataset of the anatomical site includes all anatomical features within a volume defined by the third volumetric imaging dataset.

2. The method according to claim 1, wherein: The anatomical features include hard tissue and soft tissue. 3 . The method according to claim 1 , further comprising the step of displaying the third volume imaging data on a display screen.

4. The method according to claim 1, wherein: The first imager is in a first plane in the first position and the second imager is in a second plane in the second position, the first plane and the second plane being on opposite sides of the anatomical site.

5. The method according to claim 1, wherein: The step of combining the first volumetric image data and the second volumetric image data to generate third volumetric imaging data of the anatomical region further comprises the step of combining image data sets from a third imager and a fourth imager.

6. A medical imaging system comprising: An imager configured to generate a volumetric image dataset of an anatomical region, the imager comprising: a first transducer array located on a first surface of the imager, the first array defining a first footprint; and a second transducer array positioned on a second surface of the imager, the second array defining a second footprint, the first surface being separated from the second surface to define a gap between the first surface and the second surface; in: the projected area of ​​the first footprint intersects the projected area of ​​the second footprint such that a volume beneath the gap is included in the volumetric image dataset generated by the imager; The first transducer array and the second transducer array are configured to flex apart such that the first transducer array and the second transducer array are separated; and When the first and second transducer arrays are flexed apart, the first and second transducer arrays define a gap that extends at least partially across the imager when the imager is placed over a target body area to allow for a surgical procedure.

7. A medical imaging system comprising: A first imager, the first imager comprising: a first transducer array located on the first surface; and a second transducer array located on a distal surface of the first imager, the first surface being inclined relative to the distal surface, wherein the waves generated by the first transducer array and the second transducer array are configured to generate a first image data set of an anatomical region; and A second imager, the second imager comprising: a third transducer array located on a distal surface of the second imager, the third transducer array configured to generate a second image data set of the anatomical region; and a second surface, the second surface being transverse to a distal surface of the second imager, Wherein a first surface of the first imager is transverse to a second surface of the second imager such that when the first surface faces the second surface, the first surface and the second surface define a gap.

8. The medical imaging system according to claim 7, wherein: At least one of the first transducer array and the second transducer array is substantially circular.

9. The medical imaging system according to claim 7, wherein: The first transducer array is larger than the second transducer array.

10. The medical imaging system according to claim 7, wherein: The first image data set and the second image data set are generated simultaneously.

11. The medical imaging system according to claim 7, wherein: The first image data set is generated before generating the second image data set.

12. The medical imaging system according to claim 11, wherein: The medical imaging system is configured to determine a placement of the second imager relative to the anatomical site to generate the second image data set based on the first image data set.

13. The medical imaging system of claim 12, wherein: The medical imaging system determines placement of the second imager based on stored information regarding a medical procedure.

14. The medical imaging system of claim 7, wherein: The first transducer array and the second transducer array are capacitive micromachined ultrasonic transducers (CMUT), piezoelectric micromachined ultrasonic transducers (PMUT) or any combination thereof, and the first transducer array and the second transducer array are both arranged on a substrate, and the substrate is arranged in the first imager and the second imager.

15. The medical imaging system of claim 7, wherein: The anatomical part includes an anatomical feature, and The anatomical features include hard tissue and soft tissue.

16. The medical imaging system of claim 7, further comprising a display screen for displaying at least one of: the first image data, the second image data, and a combination of the first image data and the second image data.

17. The medical imaging system of claim 7, wherein: The first image data set is generated by the first imager at a first position relative to the anatomical site, and the second image data set is generated by the second imager at a second position relative to the anatomical site.

18. The medical imaging system of claim 7, wherein: Anatomical features obstructed by any of bone, body fluid, and other image obstructions in the first image dataset are captured by the second image dataset.

19. The medical imaging system of claim 16, wherein: The first image data set, the second image data set, or a combination of the first image data set and the second image data displayed on the display screen includes at least an image data set generated by at least one of the first imager or the second imager.

20. The medical imaging system of claim 16, wherein: The display screen includes a plurality of screens, each screen being perpendicular to at least one other screen.

21. A medical imaging system comprising: An imager configured to generate a volumetric image dataset of an anatomical region, the imager comprising: a first transducer array located on a first planar distal surface of the imager; a second transducer array located on a distal surface of a second plane of the imager, wherein the distal surface of the first plane is spaced apart from the distal surface of the second plane to define a gap between the distal surface of the first plane and the distal surface of the second plane; and a third transducer array, the third transducer array being located on a surface of a third plane of the imager, wherein: a third planar surface of the imager extending from at least one of a distal surface of the first planar surface or a distal surface of the second planar surface; The surface of the third plane is inclined relative to at least one of the distal surface of the first plane or the distal surface of the second plane; and The third planar surface defines a portion of a gap between the first planar distal surface and the second planar distal surface, and Wherein a projected area of ​​the first transducer array intersects a projected area of ​​the second transducer array such that a volume beneath the gap is included in the volumetric image dataset generated by the imager.

22. The medical imaging system of claim 21, wherein: The volumetric image data of the anatomical region includes all anatomical features within the volume.

23. The medical imaging system of claim 22, wherein: The anatomical features include hard tissue and soft tissue.

24. The medical imaging system of claim 23, further comprising a display device for displaying the volumetric image data.

25. The medical imaging system of claim 24, wherein: The volumetric image data displayed on the display device is generated by combining a first volumetric image data set generated by the first transducer array and a second volumetric image data set generated by the second transducer array.

26. The medical imaging system of claim 25, wherein: When an anatomical feature in the first volumetric image dataset is obstructed by any of bones, body fluids, and other image obstructions, the anatomical feature is captured by the second volumetric image dataset.

27. The medical imaging system of claim 26, wherein: The display device includes a plurality of screens, each screen being perpendicular to at least one other screen.

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