WO2020142338A1

WO2020142338A1 - Needle insertion into subcutaneous target

Info

Publication number: WO2020142338A1
Application number: PCT/US2019/068519
Authority: WO
Inventors: Andrew COTHREL; Robert Dunki-Jacobs; Andrew LOEBS; Jill Embry
Original assignee: Xact Medical, Inc.
Priority date: 2018-12-31
Filing date: 2019-12-26
Publication date: 2020-07-09

Abstract

Real-time compensation of a needle path into tissue comprises detecting initiation of a needle insertion operation, monitoring a condition associated with the detected needle insertion operation as the needle follows a first path toward a target point, and performing a dynamic compensation modification where a change is detected in the monitored condition that deviates beyond a first predetermined threshold. Dynamic compensation is carried out by calculating a correction necessary to compensate the needle insertion operation based upon the detected change in the monitored condition, generating a likelihood that the calculated correction will result in a successful needle insertion, and transmitting a command to a delivery system that effectuates insertion of the needle based upon the calculated correction where the generated likelihood exceeds a second predetermined threshold, otherwise transmitting a command to stop the needle insertion operation before the needle breaches the tissue.

Description

NEEDLE INSERTION INTO SUBCUTANEOUS TARGET

TECHNICAL FIELD

Various aspects of the present disclosure relate to percutaneous medical procedures, such as needle insertion into a subcutaneous target. Further aspects relate to target selection, needle insertion, dynamic compensation of needle insertion, and/or combinations thereof.

BACKGROUND ART

Needle insertion into a patient can be essential for procedures such as nutrition, medications, anesthesia, chemotherapy, insertion of devices, etc. In this regard, the patient experience during a needle insertion procedure is largely dictated by the training, skill, and experience of a phlebotomist performing needle target selection and needle insertion procedures. Moreover, the accuracy and efficiency with which a needle can be inserted to a specific site within a body has a large impact on the efficiency and efficacy of a corresponding procedure.

DISCLOSURE OF INVENTION

According to aspects of the present disclosure, a process for real-time compensation of needle path into tissue is disclosed. The process includes detecting initiation of a needle insertion operation. The process also includes monitoring a condition associated with the detected needle insertion operation as the needle follows a first path toward a target point. In addition, the process involves performing a dynamic compensation modification where a change is detected in the monitored condition that deviates beyond a first predetermined threshold. The dynamic compensation can be accomplished by calculating a correction necessary to compensate the needle insertion operation based upon the detected change in the monitored condition, generating a likelihood that the calculated correction will result in a successful needle insertion, and transmitting a command to a delivery system that effectuates insertion of the needle based upon the calculated correction where the generated likelihood exceeds a second predetermined threshold, otherwise transmitting a command to stop the needle insertion operation before the needle breaches the tissue. According to further aspects of the present disclosure, a process for real-time compensation of needle path into tissue is disclosed. The process involves detecting initiation of a needle insertion operation, where the needle insertion operation is controlled based upon a needle insertion parameter. The process also involves detecting a change in a value associated with the needle insertion parameter after detecting the initiation of the needle insertion operation. The process also includes calculating a needle insertion compensation based upon the detected change. Moreover, the process involves generating a likelihood that the calculated change will result in a needle insertion that successfully engages the target. The process further includes transmitting a command to compensate for the calculated change to a delivery system that effectuates insertion of the needle where the generated likelihood exceeds a predetermined threshold, otherwise transmitting a command to stop the needle insertion operation before the needle breaches the live tissue.

According to yet further aspects of the present disclosure, a process for guiding a needle into a target point within tissue is disclosed. The process involves receiving information of an area of interest within tissue. The process also includes identifying a structure within the area of interest based on the received information. Moreover, the process involves creating a target point within the identified structure for insertion by a needle by identifying a vessel boundary for the structure, creating an eroded boundary within the identified boundary, and calculating a minimum needle depth and a maximum needle depth based on the eroded boundary, wherein the target point is between the minimum needle depth and the maximum needle depth. Also, the process includes transmitting the created target point to a delivery system that effectuates insertion of the needle. BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is an illustration of an example delivery system according to aspects of the present disclosure;

FIG. 2 is an illustration of an example graphic user interface according to aspects of the present disclosure;

FIG. 3 is an illustration of a process 300 for guiding a needle into a target point within tissue according to aspects of the present disclosure;

FIG. 4A is an image showing needle penetration into vascular tissue according to aspects of the present disclosure; FIG. 4B is an image showing another needle penetration into vascular tissue according to aspects of the present disclosure;

FIG. 4C is an image showing yet another needle penetration into vascular tissue according to aspects of the present disclosure;

FIG. 5 illustrates a side view of a vein according to aspects of the present disclosure;

FIG. 6 illustrates a process for guiding a needle into a target point within tissue according to aspects of the present disclosure;

FIG. 7 illustrates vascular deformation according to aspects of the present disclosure;

FIG. 8 illustrates a process guiding a needle into a target point within tissue; and

FIG. 9 illustrates an example needle insertion device, according to aspects of the present disclosure. MODES FOR CARRYING OUT THE INVENTION

Needle insertion into a subcutaneous target finds many applications in healthcare environments, such as to access a vein, to biopsy a tumor mass, to access a nerve, to access an abscess, etc. In this regard, needle insertion procedures can facilitate extraction, fluid delivery, energy delivery, and other desired tasks.

By way of example, currently, needle insertion into a patient is typically performed manually. While potentially convenient, manual techniques leave open the possibility that human error and human physiology can contribute to“misses” (i.e., the needle misses the target) and other related issues. As a result, the patient may experience discomfort or a more significant health consequence, which influences patient outcomes (e.g., a positive or negative health result), complication rates, and patient experience.

Further, complications of“misses” can include pneumothorax, infection, bleeding, arterial puncture, arrhythmia, air embolism, thoracic duct injury, catheter malposition, and hemothorax.

As another example, a manual needle insertion operation may target a vein, such as to administer medications (e.g., vaccinations, pain killers, etc.) via the needle or similar implement. If during administration of the medications, the needle overshoots the target vein (i.e., the needle goes through the vein, thereby exposing a portion of the needle outside of the target vein), medication may be administered into a patient’s body cavity, which may have adverse effects. A similar result may occur if the needle undershoots the target vein (i.e., the needle partially punctures the vein, but still exposes a portion of the needle outside the target vein).

Moreover, manual needle insertion operations can be time consuming. By way of example, in typical clinical experiences, the time required for central vascular access can range from 15-55 minutes, but up to two hours is also possible where a proper vein is difficult to locate or stick. This results in considerable cost, both directly and indirectly to the healthcare provider.

Moreover, there are a number of factors that extend beyond a skill level of the caregiver performing the needle insertion operation (typically a phlebotomist), which are referred to herein as“dynamic error sources.” Dynamic error sources may cause the needle to miss the target. For example, if the patient coughs during insertion of the needle, a target vein within the patient’s body may move or deform, thus causing the needle to miss the target vein. In another example, the needle may miss the targeted vein due to natural fluctuations of the vein during cycles of blood flow.

Aspects of the present disclosure solve these problems by reliably providing needle insertion into subcutaneous target (potentially in 3-5 minutes) for any clinician who needs to perform a needle-based procedure on a patient. Moreover, similar results can be derived from experienced phlebotomists, as well as clinicians who are not specialist experts but find that they must obtain subcutaneous access to a target periodically, e.g., 5-15 times per month. Subcutaneous target access is provided by automated and/or semi-automated point of care solutions that accurately calculate a target point within the target and dynamically compensate for dynamic error sources. The speed and precision brought about by aspects of the disclosure herein improves the field of needle-based procedures.

Moreover, needle delivery systems disclosed herein are simple to use, even when the target is 2 millimeters (mm) at depths that range from 3mm-50mm. An operator identifies a target using a cursor, confirms the target, and the needle delivery system takes over to perform needle placement. Needle placement can include dynamic compensation, comprised of algorithms, machine learning, sensors, system mechanics, and combinations thereof, which is capable of dynamically accounting for key target attributes to optimize targeting and compensate for patient/clinician movement, as will be described in greater detail herein. As such, in addition to drawing blood, needle delivery systems described herein can be utilized for any procedure requiring the precise placement of a needle in a part of the body that can be ultrasound visualized, such as for solid tumor biopsy; gene therapy; regional anesthesia; electrode placement; biomarker delivery; precision injections; precision aspirations; brachy therapy; and tumor ablation, etc.

Needle Delivery System

Referring now to the figures, and in particular FIG. 1, an example needle delivery system 100 comprises an imaging system 102, a probe 104, and a needle insertion device 106.

The imaging system 102 generates data (e.g., positional instructions) to send an object (e.g., needle tip) precisely to a point in space. For purposes of clarity and conciseness, the various disclosures herein are primarily directed toward use of ultrasound (e.g., brightness-mode ultrasound, motion-mode ultrasound, etc.) as the imaging system 102. Ultrasound provides several key advantages, e.g., an ability to show depth perception and establish accurate real-time construction of three-dimensional (3-D) objects from a single image orientation (i.e., does not need multiple views to create a 3-D image). However, aspects of the present disclosure are not strictly reliant on ultrasound technology, and therefore is not limited thereto. For instance, various imaging modalities can be utilized alone or in combination, so long as targeting solutions can be calculated in real-time for below-the-skin targets.

In various embodiments, the imaging system 102 includes a processor 112 communicably coupled to related hardware 114 such as a controller 116, storage medium(s) 118, network adapter 120 (for communication with various internal external networks), and interface(s) 122 (e.g., to interface with the probe 104), etc.

The storage medium 118 can store program code 124 that can be read out and executed by the processor 112 to carry out imaging functions and/or other functions, e.g., to cooperate with the needle insertion device 106 as described more fully herein.

In various embodiment, the imaging system 102 may have its own display screen with a graphical user interface (GUI) 126 integral with the imaging system 102, which an operator of the imaging system 102 can interact with during operation thereof. Alternatively, the imaging system 102 can connect to an external display device, e.g., a generic display device such as a stand-alone display (e.g., television, monitor, etc.) or an independent processing device such as a smart device (e.g., smartphone, tablets, laptops, etc.). The probe 104 is an ultrasound probe in the above example, which interfaces with the imaging system 102 and the needle insertion device 106. In practical applications, the probe 104 is integrated into the needle insertion device 106. However, the probe 104 can be a separate device. Moreover, the probe 104 can include one or more sensors, the specific type of which will depend upon the imaging modality.

The needle insertion device 106, includes a processor 132 communicably coupled to associated hardware 134. Example hardware 134 can include a controller 136, storage medium(s) 138, network adapter 140, a needle cartridge interface 142, and motors and actuators 144 to guide a needle cartridge (e.g., when the needle cartridge contains a needle). Example hardware 134 can also include a frame grabber 146, which can receive real-time data in either digital or analog formats from the imaging system 102, and forward that data to the processor 132 for processing, etc., an image processor 148, path planning circuitry 150, and one or more optional interfaces 152 (e.g., to support additional sensors, probes, input/output devices, etc.). Th

In this regard, the processor 132 may be integrated into the needle insertion device 106, implemented through an independent processing device such as a smart device (e.g., smartphone, tablets, laptops, etc.), combination thereof, etc. The controller 136 of the needle insertion device 106 interacts with the processor 132 to control a needle insertion operation, such as by interfacing with mechanical structures to implement one-dimensional (ID) position control, two-dimensional (2D) position control, three-dimensional (3D) position control, rotation, penetration velocity of a needle coupled to a needle cartridge, combinations thereof, etc., depending upon the specific configuration of the mechanical operation and capability of the needle insertion device 106.

In other embodiments, the cartridge can support a variety of tools or devices such as biopsy devices, ablation devices (including radiofrequency ablation (RFA) devices), biopsy guns, cryoprobes and microwave probes can be used in conjunction with the needle insertion device 106.

In various embodiments, once the frame grabber 146 forwards data to the processor 132, the processor 132 can utilize one or more image processors 148 and one or more path planners 150, e.g., to perform calculations necessary for path planning and needle point placement. The image processor(s) 148 analyze the information provided by the imaging system 102 and frame grabber(s) 146, detect areas of interest (AOI), and tracks movements of the corresponding cartridge loaded into needle insertion device 106. In example embodiments, the path planner 150 searches for an optimal trajectory of a needle carried by a cartridge, monitors movement of the cartridge, provides real time adaptation if necessary, combinations thereof, etc., as disclosed in greater detail herein.

Moreover, the needle insertion device 106 may include various interfaces 152 that work in conjunction with the needle insertion device 106. Example interfaces 152 link peripherals to the controller 132, such as hand-held controllers, joysticks, and other hardware for interaction with an operator of the needle insertion device 106.

Further, the needle insertion device 106 includes program code 154 (e.g., stored in the storage 138) such that when the program code 154 is read out and is implemented by the processor 132, the various components cooperate to effectuate general operation of the needle insertion device 106. The needle insertion device 106 may also include its own display with a GUI 156 (hereinafter needle insertion device-GUI), and/or use an external GUI 126 (e.g., the needle insertion device 106 can share display screen space with the imaging system display, e.g., via shared/divided screen space, overlays, combinations thereof, etc.).

In various implementations, the imaging system 102 may directly communicate with the needle insertion device 106. In other implementations, the imaging system 102 may communicate with the needle insertion device 106 through an external interface 160 (shown as“EX-INTERFACE” in FIG. 1) that has its own processor, storage, program code, GUI, etc., or a combination thereof (e.g., a dedicated smart device).

In operation, the imaging system 102 can function as an autonomous and powered system. Once a user selects a target, the needle delivery system 100 takes over, calculating the needle path, actuating needle movement, ensuring a straight path to the correct depth on first attempt, minimizing tissue damage from side-to-side“finding” movements of the needle tip inherent in manual methods.

Graphical User Interface

In certain embodiments, rather than simply targeting the spot on the ultrasound screen selected by the clinician, the needle delivery system 100 recognizes the target, e.g., the system may recognize the target as a vessel, tumor, mass, nerve, abscess, etc. In the case of a vessel, the system may further differentiate a vein from an artery, determine vessel boundaries, select the optimal location within those vessel boundaries for use as the target point (i.e., the location that maximizes the probability of successful vessel entry), combinations thereof, etc.

Now referring to FIG. 2, an example GUI 200 is illustrated. The GUI 200 or similar variations thereof may be implemented on the GUIs as disclosed in FIG. 1, (i.e., GUI 126, needle insertion device-GUI 156, etc.). The GUI 200 may be implemented on a dedicated display screen, or displayed through a web-based interface (e.g., web browser). Various controls and functions of the GUI 200 may vary depending on a particular system or device being used, but generally the GUI 200 comprises a viewing area 202 (e.g., for displaying images from the imaging system 102) that may include overlay graphics.

The viewing area 202 may also include references markers 204 (e.g., fiducials, or numbered measurements) to indicate position and/or serve as a center point of axis. Moreover, the viewing area 202 can display a target marker 206 that indicates a potential target point for insertion by a needle as described in greater detail herein.

Moreover, the GUI 200 further comprises viewing area controls 208 for interaction with, and manipulation of, the viewing area 202 such as adjustments for gain, resolution, clipping, depth, etc. The viewing area controls 208 can enable an operator to toggle through various modes (e.g., filters, different visible spectrums, etc.) or save preferences.

The GUI 200 also comprises delivery system controls 210 such as“record” (which allows for real time recording of the viewing area 202),“take a picture” (which takes a snapshot of the viewing area 202),“stop” (which can disable aspects of the delivery system, see reference number 100 in FIG. 1),“zero point” allows for homing of the delivery system (e.g., returning components, such as motors and actuators to a home or initial position),“enable” (which permits activation of the motors and actuators),“set control device” (e.g., joystick, probes, etc.),“adjust speed” of delivery system components, change views between views (e.g.,“front mode”, which displays a front view from the ultrasound and“side mode”, which displays a side view from the ultrasound).

The GUI 200 may further comprise a numeric keypad that permits the operator to send commands to the delivery system components directly, a coordinate display that displays various positional coordinates (e.g., x-axis and y-axis) of the needle during operation of the delivery system, and an informational display that displays messages to the operator (e.g., for instructions, warnings (e.g., such as for debugging purposes), etc.). The aforementioned disclosure of the GUI 200 is merely an example of potential configurations of controls and interface elements, and is by no means limiting.

Target Identification and Target Point Selection

Referring to FIG. 3, a process 300 for guiding a needle into a target point within tissue is disclosed.

Aspects of the present disclosure are directed toward creating a target point within a structure (e.g., a vein, tumor, mass, nerve, abscess, etc.) and guiding a needle thereto. Generally, the process 300 can be executed directly on a needle insertion device (see reference number 106 in FIG. 1), or as part of an overall delivery system (see reference number 100 in FIG. 1) where the process is executed from a dedicated local device (e.g., desktop, etc.) remotely on an internal network or an external network (e.g., the cloud), combination thereof, etc.

The process 300 comprises receiving at 302 information of an area of interest within tissue. In typical embodiments, the area of interest will be in living tissue, but such need not be the case. In various embodiments, an ultrasound (see imaging system 102 in FIG. 1, by a processor 112 executing program code 1124 with storage 118) is used to capture images of a particular region of a patient’s body (e.g., using a probe 104 in FIG. 1). However, there are many variations of ultrasound, thus ultrasound is not constrained to a methodology or type.

In various embodiments, receiving 302 positional information comprises receiving positional information of the area of interest via brightness-mode ultrasound, motion-mode ultrasound, color doppler ultrasound, power doppler ultrasound, directional power doppler ultrasound, pulsed wave doppler ultrasound, or a combination thereof.

Further, the process 300 comprises identifying at 304 a structure (e.g., vascular structure, tumor, mass, nerve, abscess, etc.) within the area of interest based on the received information. In an example context of phlebotomy, for instance, the ultrasound is used to capture images of a patient’s vascular structures (e.g., veins and arteries) for blood drawing purposes.

In various embodiments where the structure comprises a vascular structure, identifying 304 the structure further comprises discriminating (e.g., distinguishing) between an artery and a vein within the tissue. Ascertaining whether or not a particular vascular structure is an artery or a vein has significance from both a patient perspective and an operator perspective. Veins are usually favored over arteries for operations involving a needle, whether for blood drawing purposes, or for purposes of administering medications for numerous reasons.

From a purely practical standpoint, veins are easier to access due to their superficial location within skin compared to the arteries, which are located deeper under the skin. Veins also have thinner walls (much less smooth muscle surrounding them) than arteries, and have less innervation, thus piercing veins with a needle requires less force. Also, due to veins having thinner walls, veins tend to be larger than a corresponding artery. As a result, veins tend to hold more blood, thus making blood collection easier and faster. Moreover, venous pressure is also lower than arterial pressure, so there is less of a chance of blood seeping back out through a puncture point before the artery heals.

As with most, if not all medical procedures, there is a possibility of adverse health effects from puncturing the artery as opposed to the vein. Blood flow in veins tends to go from small vessels to larger and larger vessels, thus reducing a chance of a vessel being blocked by an embolism before it reaches a patient’s heart/lungs. Blood flow in an artery, on the other hand, tends to move into smaller and smaller vessels, eventually ending in capillaries (which are very small), which increases chances that an air bubble introduced by a blood draw or an intravenous line (IV) could block capillaries, potentially leading adverse health effects.

Accordingly, structural characteristics between veins and arteries can be used to discriminate between them by measuring deformation characteristics of the vascular structure. In this regard, images from the ultrasound (e.g., 102 in FIG. 1) can be used as a basis for measuring deformation characteristics of the vascular structure by observing and tracking cycles during blood flow, since ultrasound allows for vascular imaging in real-time.

A vascular structure can be designated as a vein if the deformation characteristics of the vascular structure exceeds a pre-determined threshold. The vascular structure can be designated as an artery if the deformation characteristics of the vascular structure do not exceed the pre-determined threshold. Generally, the more the vascular structure deforms, the more likely it is that the vascular structure is a vein.

By way of illustration, and not by way of limitation, power doppler capabilities of the underlying ultrasound system can be utilized to reliably identify veins and arteries. This capability may be improved by incorporating vessel boundary data into an identification and differentiation algorithm. Moreover, the process 300 further comprises creating at 306 a target point within the identified structure for insertion by a needle. According to aspects herein, targeting optimization provides the capability to optimize the“target within the target” to direct the needle tip to that point in space within the target (e.g., a selected blood vessel) that provides the optimal statistical likelihood of successful structure entry by the needle.

In this regard, select embodiments herein utilize image processing to identify only structures that can be hit as potential targets.

In an example of vascular access, the system uses image processing to identify only vessel structures that can be hit as potential targets. In an example implementation, the needle delivery system defines the boundary of the vessel inner wall for all vessels identified, e.g., by determining and tracking boundaries for regular and irregular vessel geometries that may be changing in real-time. Once boundaries for identified vessels are determined, the needle delivery system’s algorithms can screen those vessels to take inherent (such as static) system errors into account and eliminate vessels that cannot be accessed with even the smallest gauge needle selected. In an example embodiment, the operator can select from those vessels pre-screened as valid target vessels (e.g., as displayed on a GUI - See GUI 126 and/or GUI 156 FIG. 1; GUI 200, FIG. 2, etc.). In example embodiments, the needle delivery system can also recommend a maximum needle gauge specific to the user selected target (vessel in this example). In addition to needle gauge, this recommendation may also consider the length of the needle’s bevel cut, and any other relevant parameters.

In an example embodiment, the target point is created 306 by identifying at 308 a boundary for the structure, creating at 310 an eroded boundary within the identified boundary, and calculating at 312 a minimum needle depth and a maximum needle depth based on the eroded boundary, wherein the target point is within between the minimum needle depth and the maximum needle depth.

In this regard, the minimum needle depth and the maximum needle depth can be calculated in multiple ways. In one example, the process 300 creates a target area in the form of a trapezoidal bounding box (TBB) by using projected needle paths. Based on the TBB and the eroded boundary, the process 300 can establish both the minimum needle depth and the maximum needle depth. These calculations are described in greater detail herein.

Yet further, the process 300 comprises transmitting at 314 the created target point to a delivery system that effectuates insertion of the needle. An example delivery system can be found in FIG. 1 for reference (e.g., an imaging system 102 via a network adapter 120, sends the created target point through an external interface 160 to a needle insertion device 106).

Further, the process 300 in various embodiments may incorporate escape mechanisms that halt the process or otherwise generate an alert if, based on the target point, the needle cannot be inserted into the vascular structure within a predetermined degree of confidence due to various factors. For instance, if the target point is calculated such that a bevel of the needle is not entirely within the structure when the target point is reached, the process 300 may issue an alert.

Referring now to FIG. 4A, FIG. 4B, and FIG. 4C generally, a series of images of a needle 400 are illustrated, which comprise a shaft 402, a bevel 404, and a lumen 406 (the lumen is the cavity or hollow portion that drawn blood flows through, or medication is dispensed through, in the needle) interacting with a vascular structure 408 (e.g., vein). FIG. 4A illustrates effects and consequences of undershooting and FIG. 4C illustrates effects and consequences of overshooting the vascular structure 408 (e.g., vein).

Ideally, the bevel 404 and the lumen 406 are positioned completely within the vascular structure 408 as illustrated in FIG. 4B. If the needle undershoots as illustrated in FIG. 4A, or overshoots as illustrated in FIG. 4C, the vascular structure 408, fluids may be introduced through the lumen 406 and leak into interstitial space 410 (e.g., a body cavity) surrounding the vascular structure 408. In instances where a catheter is used, a guide wire may damage the vascular structure (e.g., vessel intima) or surround tissue in the interstitial space 410. Other consequences/significant morbidities such as pneumothorax are also possible in overshoot scenarios.

In the image of FIG. 4A, the needle 400 has undershot the vascular structure 408, which results in the bevel 404 and the lumen 406 being partially outside of the vascular structure 408 and inside the interstitial space 410.

In the image of FIG. 4B, the needle 400 is properly inserted, wherein both the bevel 404 and the lumen 406 are positioned completely within the vascular structure 408.

In the image of FIG. 4C, the needle 400 that has overshot the vascular structure 408, which results in the bevel 404 and the lumen 406 being partially outside of the vascular structure 408 and inside the interstitial space 410 similarly to the image of FIG. 4A.

Some embodiments herein recognize that there can be inherent errors that should be considered. Inherent, or static errors can be broken into controllable and uncontrollable categorizations. Controllable static errors are those errors that are a function of the systems and manufacturing process that can be compensated through controls, sensors, and calibration. Examples of controllable static errors include Ultrasound depth error; Mechanism error (tolerance stacks, repeatability); Cartridge/needle manufacturing and assembly, etc. On the other hand, uncontrollable static errors are those errors that cannot be compensated because they cannot be characterized in advance of the needle delivery system use. An example of an uncontrollable static error may include patient-to-patient tissue property variability. In some embodiments, uncontrollable static errors may not be able to be corrected based on direct mathematical correction.

Referring to FIG. 5, a schematic diagram illustrates a side view of a target 500. More particularly, FIG. 5 illustrates a geometric construction of a trapezoidal boundary box using a calculated needle path (with angular error) and the length of the bevel on the needle. Target, Min and Max depth parameters shown, where the view is in the X-Y plane.

In this regard, FIG. 5 illustrates an example of how the target point is created (e.g., in the process 300). In FIG. 5, the target 500 is bisected by an ultrasound image plane 502 from an ultrasound, which enables identification of a target boundary 504. Based on the target boundary 504, the eroded boundary 506 can be created.

The eroded boundary 506 accounts for variables such as errors in ultrasound imaging relative to actual anatomy (e.g., signal noise, disruptions, etc.). Effectively, the eroded boundary 506 is created by taking the target boundary 504 and subtracting out accounted variables.

In various embodiments, calculating a minimum needle depth 508 and a maximum needle depth 510 based on the eroded boundary 506 comprises creating a target area 512, the target area 512 based on projected needle paths 514 that intersect the imaging plane 502 within the eroded boundary 506, wherein the target area 512 is positioned such that a distance along the imaging plane (a) is equal at a most proximal point 516 of the target area 512 to the eroded boundary 506 (al) and at a most distal point 518 of the target area 512 to the eroded boundary 506 (a2). Stated differently, in an example implementation, the distance from (al) to the eroded boundary 506 should be the same as (a2) to the eroded boundary 506. The target point 520 is between the most proximal point 516 and the most distal point 518 along the imaging plane 502.

Moreover, such embodiments further comprise offsetting from the calculated target point 520, the distance along the imaging plane (a), in a direction to establish the minimum needle depth 508 and offsetting from the calculated target point 520, the distance along the imaging plane (a), in an opposing direction to establish the maximum needle depth 510 as shown in FIG. 5. With the minimum needle depth 508 and the maximum needle depth 510 set, a target depth 522 can be set as well. In this regard, calculating the target point 520, minimum needle depth 508, maximum needle depth 510, and related calculations can be performed by an imaging system (e.g., program code 124 in storage 118 that instructs a processor 112 to perform the calculations), a needle insertion device (e.g., program code 154 in storage 138 that instructs a processor 132 to perform the calculations), or a combination thereof.

In certain embodiments, as noted above, placement of a trapezoidal bounding box is implemented such that the distance along the ultrasound imaging plane to the eroded boundary is the same at the most proximal and distal portions, i.e., al=a2. Here, minimum and maximum depths are then also (a) away from a designated target depth.

As shown in FIG. 5, the target area 512 visually creates a trapezoidal bounding box. Note that in FIG. 5, the view is of the anatomy orthogonal to the ultrasound image to more clearly show the effects of mechanical arm angle error. The eroded boundary accounts for the error in ultrasound imaging relative to actual anatomy. The trapezoidal bounding box accounts for nominal physical characteristics of the needle (e.g., needle length, needle bevel, including angle of bevel and orientation of bevel, gauge, etc.), as-built characteristics of the needle, static electro-mechanical errors, or combinations thereof.

According to some embodiments herein, the needle delivery system’s algorithms statistically assess the likelihood of successful structure entry by the needle and will not allow the needle delivery device to fire if the probability of successful entry is too low (e.g., a 98% threshold, i.e. the user can fire needle delivery system and miss the vessel 2 out of 100 attempts, 95%, or any other established threshold). By way of example, generally, the trapezoidal bounding box reflects a period of time of reasonable positional and structure boundary stability, which is likely to successfully deliver the needle within an acceptable margin of error (e.g., a 2% error rate, or 98% success rate). In various embodiments, long sides of the trapezoidal bounding box (i.e., the sides that run parallel to the needle paths 514) match a length of the bevel of the needle (shown as 524 in FIG. 5).

A trapezoidal bounding box that is entirely enclosed within the eroded boundary 506 typically represents a condition in which it is ideal to transmit the created target point to a delivery system for insertion of the needle. If the proposed target solution creates a trapezoidal bounding box that is totally enclosed within the eroded boundary 506 over some period of time that reflects reasonable positional and structure boundary stability, then that solution is likely to successfully deliver the needle (i.e., a valid targeting solution). The minimum and maximum target depth points are function of the intersection of the trapezoidal bounding box with the ultrasound image plane. The target depth is a function of the minimum and maximum depth points. Collectively, these points are referred to as the “Targeting Solution” or“Target Point.” For example, in the process 300, an embodiment thereof may comprise transmitting the created target point to a delivery system only when the created trapezoidal bounding box is entirely within the eroded boundary.

In some embodiments, calculating a target point within a target area based on projected needle paths that intersect an imaging plane within the eroded boundary, comprises creating a trapezoidal bounding box using multiple needle paths, e.g., three needle paths.

Also, some embodiments comprise creating an eroded boundary within the identified vessel boundary by modifying the eroded boundary based on a needle gauge size of the needle and/or a bevel size of the needle.

Moreover, the trapezoidal bounding box may be implemented for a single fixed point in time, or the trapezoidal bounding box may be implemented intermittently and/or dynamically as described in greater detail herein.

Example Trapezoidal Engine

In an example implementation, a real-time trapezoidal solution engine is composed of two physical computational entities. The static portion of the trapezoidal solution engine (TSE-S) is executed in the needle delivery system ultrasound console (e.g., see 102, FIG. 1; GUI 200, FIG. 2) creating a preliminary GO-NO-GO signal. The dynamic portion of the trapezoidal solution engine (TSE-D) is executed in the needle insertion device (e.g., see 106, FIG. 1) creating a final GO-NO-GO signal. The TSE-S and TSE-D portions communicate through a low-bandwidth channel between the needle delivery system console and the needle insertion device and integrated into standard ultrasound probe connector and cabling.

The TSE-S uses knowledge of the static error sources in the needle delivery system along with ultrasound image information to create the trapezoidal bounding box within which a possible targeting solution can be found, as described more fully herein. In example embodiments, the trapezoidal bounding box is created in two modes: i) Regular Update and ii) Dynamic Update. Regular Update mode creates new solutions in a fixed time interval. In Dynamic Update mode, solution creation can be terminated and immediately restarted due to a signal from the needle insertion device should a dynamic condition invalidate its last provided targeting solution. If the TSE-S determines current, TBB-based, information yields a probability of success higher than the threshold (e.g., 98% in an example implementation), then the GO signal will be sent to the needle insertion device providing the minimum depth, maximum depth and target depth (the target solution). Otherwise, the NO-GO signal will be sent, invalidating any existing target solution.

The TSE-D uses real-time dynamic motion data gathered by the needle insertion device. In an example implementation, the fundamental TSE-D strategy is to register the 6D (x, y, z, roll, pitch, yaw) orientation of the needle delivery system when the TSE-S communicates a target solution and then use deviations from that 6D orientation to determine if the needle delivery system’s arm angle and stroke length can be adjusted to accurately deliver the needle within the region specified by the target solution last provided by the TSE-S. If an adjustment can be made, the needle delivery system’s arm angle is adjusted to accommodate the new 6D orientation of the needle delivery system. If the TSE- D can’t accommodate the requested target solution, then it will send a message to the TSE- S requesting that a new solution be provided.

When the operator actuates a“Fire” control (e.g., a fire button located on the needle insertion device), the needle insertion device sends a message to the TSE-S notifying it that a“Fire” request has been made. The TSE-S will send an updated target solution to the TSE-D which then verifies the solution is reachable. If it is reachable, the arm angle is set and the needle is advanced to the target point.

Target Identification Advantages

Target identification under aspects of the present disclosure provide a wealth of advantages over existing solutions. For instance, leveraging ultrasound and its ability to show depth perception and establish accurate real-time construction of three-dimensional (3-D) objects from a single image plane (i.e., does not need multiple views to create a 3-D image) obviates a need for pre-procedure imaging and target solutions, thus saving time for both an operator and a patient. Further, aspects of the present disclosure can recognize tissue, identify a vessel, differentiate a vein from an artery, determine vessel boundaries, and calculate an optimal location within those vessel boundaries for use as a target point (i.e., a location that maximizes the probability of successful vessel entry) automatically in a matter of seconds with a high degree of accuracy, which cannot be replicated by a human alone. Once the target point has been calculated, that target point can be transmitted to a needle insertion device for actuation of the needle insertion either autonomously, or upon approval from an operator. Moreover, analogous capabilities can be applied to structures such as a tumor, mass, nerve, abscess, etc., as noted more fully herein.

For instance, identifying a structure within the area of interest based on the received information can comprise identifying a tumor mass structure within the area of interest based on the received information. Here, identifying a boundary for the structure comprises identifying a tumor mass boundary for the tumor mass structure. Analogously, identifying a structure within the area of interest based on the received information can comprise identifying a nerve structure within the area of interest based on the received information. Here, identifying a boundary for the structure comprises identifying a nerve boundary for the nerve structure. Again, analogously, identifying a structure within the area of interest based on the received information can comprise identifying an abscess structure within the area of interest based on the received information. Here, identifying a boundary for the structure comprises identifying an abscess boundary for the abscess structure.

Once actuation has been approved, aspects of the present disclosure actuate needle movement, ensuring a straight path to a correct depth (i.e., the target point) on a first attempt, minimizing tissue damage from side-to-side“finding” movements of the needle tip inherent in manual methods.

Moreover, aspects of the present disclosure can be implemented in a variety of delivery system configurations. For example, the process 300 can be implemented on a fixed system, whereby a patient and/or the delivery system is fixed in position (e.g., a chair that fixes the patient’s arm to a surface to minimize movement. In another example, the process 300 can be implemented on a hand-held configuration where neither the patient nor the delivery system are in a fixed configuration, which increases freedom of use as well as overall speed in terms of“set-up” time. In addition, the hand-held configuration also allows operators to orient the delivery system in a variety of angles that may not be possible under other solutions (e.g., in a vertical configuration).

As illustrated above, properly locating a structure and establishing a target point within that structure requires both a firm understanding of anatomy and a firm understanding of imaging technology. By using an unconventional approach of combing calculating eroded boundaries and/or trapezoidal bounding box with imaging technology (e.g., ultrasound), it is possible to insert a needle into an appropriate vascular structure with high accuracy, high speed, and little to no operator involvement.

Target Validation

In an example embodiment, once a needle is selected and a cartridge is installed in the needle insertion device (106 - FIG. 1), a selected target boundary is continuously analyzed and compared to a static“error envelope” (e.g., a 3-D geometry within which the needle delivery system is confident that the needle tip will arrive on target, e.g., 98% confidence in preceding examples). Also, a targeting solution is created. With static conditions, once inherent system errors are accounted for in optimal target point calculations, the needle delivery system would be ready to deploy. However dynamic error sources can have a significant impact.

For instance, by embodying a needle delivery system as a handheld point of care solution, there are a number of factors that can affect first actuation success rates, such as movement from patient respiration, pulse, and voluntary/involuntary muscle contraction, and/or changes in clinician hand position or degree of pressure transmitted through needle delivery system to the patient’s skin can all cause changes in vessel boundaries needle delivery system needs to be responsive to these dynamic changes to maximize probability of successful vessel access.

Generally, changes in target points due to dynamic error sources can have various effects depending on the delivery system. For example, a first delivery system may calculate a target point, transmit the target point to a needle insertion device, and actuate the needle to travel to the target point without further corrections. In such a static system, without the ability to detect changes in relevant factors, which could impact the validity of the needle path (which was calculated based on initial target position), the static system would fire at the initially calculated target point, which may result in an unacceptably high rate of“misses”, overshoots, undershoots, etc., in certain applications. In another example, a second delivery system calculates a target point, transmits the target point to a needle insertion device, and re-checks the target point to determine whether or not a change (e.g., patient has moved) has impacted the target point. The re check can be accomplished by using multiple inputs, such as accelerometer readings and/or image analysis to track changes in shape and/or geometry of the vascular structure. If the change(s) renders the initially calculated target point invalid (e.g., not reachable at 98% probability), the needle insertion device will not actuate the needle, thus preventing “misses”. However, the“no fire” events may lead to frustration from the patient and/or the operator. While suitable for some uses, the second system can be improved upon under various aspects of the present disclosure.

Dynamic Target Point Compensation

Some embodiments of the present disclosure not only accurately set a target point, which is used to set a path for the needle to travel for the target, but also dynamically compensate for dynamic error sources that may interrupt or change the target point (or path of a needle) as described in greater detail herein.

Referring briefly back to FIG. 1, as noted above, the needle insertion device 106 can include one or more interfaces 152. These interfaces 152 enable the needle insertion device to attach to structures for dynamic updating. For instance, an interface 152 can support sensor inputs, such as accelerometers to obtain accelerometer readings, reflecting device movement. Other interfaces 152 can interface to probes, sensors, or other devices that detect real-time changes in vessel shape/geometry.

Accordingly, aspects of the present disclosure provide for a delivery system (or process) that, instead of refusing to actuate the needle in the event of a change, determines if an altered angle of entry and/or distance of needle travel can“re-validate” a target point and result in a successful needle deployment and entry into the target structure. If re- validation is indeed possible, aspects of the present disclosure will automatically alter the target point within the target structure and issue instructions (arm angle and stroke length) to successfully enter the target structure.

By considering relative motion of the needle actuation device with respect to the patient and change of location and/or shape of the vascular structure, the target point may be dynamically adjusted. While change in location and/or shape of the target structure can alter the target point, not all relative motion will alter the target point. A Process for Dynamic Compensation

Now referring to FIG. 6, a process 600 for real-time compensation of needle path into tissue is disclosed. The process 600 can be carried out by the needle delivery system 100 (FIG. 1), utilize the GUI 200 (FIG. 2), incorporate the various processes, definitions, embodiments, and figures disclosed herein (e.g., the process 300, including calculation methodologies therein), and can thus be combined in any combination of elements described with reference to any of the preceding figures and/or description. In this regard, not every disclosed element need be incorporated.

The process 600 comprises detecting at 602 initiation of a needle insertion operation. For example, a needle insertion device having received a target point receives an initiation authorization from an operator of the delivery system to actuate the needle (e.g., initiation from an operator via an interface such as 152 in FIG. 1). In another example, the initiation can be autonomously directed via the process 600).

The process 600 further comprises monitoring at 604 a condition associated with the detected needle insertion operation as the needle follows a first path toward a target point.

In various embodiments, the process 600 comprises monitoring for a dynamic error source capable of altering the first path. For instance, monitoring for a dynamic error source capable of altering the first path may comprise monitoring for rhythmic motion and/or transient motion by receiving movement data from motion sensors coupled to the delivery system.

Monitoring for a dynamic error source capable of altering the first path may also comprise monitoring for patient respiration, changes in patient pulse, voluntary muscle movements, involuntary muscle movements, change in a physical dimension of the tissue, or a combination thereof, by receiving movement data from one or more motion sensors coupled to the delivery system.

In various embodiments, the process 600 utilizes one or more motion sensors (e.g., accelerometers, nine-degree of freedom (9DOF) sensors, MEMS-based Magnetic, Angular, Rate and Gravity (MARG) sensors, etc.) to detect both rhythmic motion (e.g., patient breathing cycles, natural movement cycles from blood flow, etc.) and transient motion (e.g., movement of the operator, movement of the patient, etc.). Motion sensors and associated components can collect and analyze data during the needle insertion operation. In this regard, sensors of the needle insertion device can be used to separate out heart rate, breathing rate, and operator tremor signals to provide an indication of larger-scale gross motions that could adversely impact accurate delivery of the needle. Further, data collected from previous uses or sessions (e.g., data from a prior session with the patient, or sessions from other patients) can be accessed and used to further enhance sensing and predictive abilities.

Further, correlations from analyzed data can used to learn vessel response patterns, respiratory patterns, heart rate, etc. and predict changes in boundary sizes for incorporation into the process 600.

Also, an ultrasound (e.g., 102 in FIG. 1 receiving image data from the probe 104) can be used to systematically or continuously monitor progress of a needle in relation to the target point.

Moreover, the process 600 comprises performing at 606 a dynamic compensation modification where a change is detected in the monitored condition that deviates beyond a first predetermined threshold. For instance, an example dynamic compensation comprises calculating at 608 a correction necessary to compensate the needle insertion operation based upon the detected change in the monitored condition.

The correction necessary to compensate the needle insertion operation may vary based on the detected change. For instance, in the example application of vascular access, if the patient coughs, a change of equilibrium in the patient’s body may cause various vessels to expand, contract, move, or a combination thereof. In this regard, calculating a correction necessary to compensate the needle insertion operation based upon the detected change in the monitored condition may comprise calculating the correction based on a size of the target point, a shape of the target point, a travel path to the target point, an angle of the first path, or a combination thereof.

Referring briefly to FIG. 7, for the example case of vascular access, examples of vessel deformation are illustrated based on various changes. FIG. 7, however, is merely illustrative and is not all encompassing as vessel deformation can change radically based on a patient’s age, genetic make-up, overall health, etc.

In FIG. 7 at 702, a patient is in a neutral state at 704, the block at 704 represents pressure against a patient’s skin 706 (or pressure in general within the patient’s body during a particular state). A target point 708, which is represented by a tip of the arrow, is in a lumen 710 of a vessel 712 (e.g., vein). At 714, the patient is in an inhale state 716. Negative pressure on the skin 706 slight elongates the vessel 712, thus shifting the target point 708 downward.

Oppositely at 718, where the patient is in an exhale state 720. Positive pressure on the skin 706 slight compresses the vessel 712, thus shifting the target point 708 upward.

At 722, the patient is in a cough inhale state 724, which is an exaggerated version of the inhale state 716. Negative pressure on the skin 706 significantly elongates the vessel 712, thus shifting the target point 708 downward.

Oppositely at 726, the patient is in a cough exhale state 728, which is an exaggerated version of the exhale state 720. Positive pressure on the skin 706 significantly compresses the vessel 712, thus shifting the target point 708 upward.

Accordingly, FIG. 7 illustrates how changing conditions, even minor changes, can have an impact on the target point 708. The impact on the target point 708 can be even more significant if the needle is a lower gauge (i.e., thicker) or the vessel 712 is smaller than average (e.g., capillary).

Moreover, FIG. 7 only represents vessel 712 changes based on patient body changes, and does not factor in other variables such as an operator moving during the needle insertion operation, each of which may require different calculations to compensate for. Other variables that may influence the calculation include a size of the target point, a shape of the target point, a travel path to the target point, an angle of the first path, or a combination thereof.

Referring back to FIG. 6, the process 600 comprises generating at 610 a likelihood that the calculated correction will result in a successful needle insertion. In various embodiments, an approach similar to that of the process 300 may be used (e.g., creating a target area/trapezoidal bounding box, calculating minimum/maximum distance, etc.).

Moreover, the process 600 comprises transmitting at 612 a command to a delivery system that effectuates insertion of the needle based upon the calculated correction where the generated likelihood exceeds a second predetermined threshold, otherwise transmitting a command to stop the needle insertion operation before the needle breaches the tissue.

For example, in various implementations, if the likelihood that the calculated correction will result in a successful needle insertion is less than a predetermined percentage (e.g., 98%, 95%, etc.) the process 600 may issue a stop command and/or retract the needle. The likelihood expressed as a percentage is merely an example, is by no means limiting. In some embodiments, transmitting the command to stop further comprises transmitting a command to retract the needle to a default position.

In various embodiments, the process 600 further comprises transmitting instructions to the delivery system that restricts an axis of movement for the needle once the needle breaches the tissue. Restricting an axis of movement in some instances can prevent or minimize tissue damage. For example, if the needle has breached a patient vein, then side-to-side motion may tear the vein and cause excess bleeding.

A Second Process for Dynamic Compensation

Now referring to FIG. 8, a process 800 for real-time compensation of needle path into live tissue is disclosed. The process 800 can incorporate the various processes, definitions, embodiments, and figures disclosed herein (e.g., the process 300 or 600 using the delivery system 100, viewable on the GUI 200, including calculation methodologies therein), and can be combined in any combination of elements described with reference thereto. In this regard, not every disclosed element need be incorporated.

The process 800 comprises detecting at 802 initiation of a needle insertion operation, where the needle insertion operation is controlled based upon a needle insertion parameter. Analogous to the process 600, initiation can come from an operator, or performed autonomously by the process 800 by meeting pre-determined conditions (e.g., success rate is 98% or higher, 95% or higher, etc.). Again, the predetermined condition need not be expressed as a percentage.

Further, the process 800 comprises detecting at 804 a change in a value associated with the needle insertion parameter after detecting the initiation of the needle insertion operation. In various embodiments, the process 800 comprises detecting a dynamic error source capable of altering the first path. Examples of a dynamic error source are analogous to those listed herein (e.g., rhythmic motion, transient motion, monitoring for patient respiration, changes in patient pulse, voluntary muscle movements, involuntary muscle movements, change in a physical dimension of the tissue, or a combination thereof).

Thus, for instance, detecting a dynamic error source capable of altering the first path may comprise detecting rhythmic motion and/or transient motion by receiving movement data from motion sensors coupled to the delivery system. Detecting a dynamic error source capable of altering the first path may also comprise monitoring for patient respiration, changes in patient pulse, voluntary muscle movements, involuntary muscle movements, change in a physical dimension of the tissue, or a combination thereof by receiving movement data from motion sensors coupled to the delivery system.

Moreover, the process 800 comprises calculating at 806 a needle insertion compensation based upon the detected change.

Yet further, the process 800 comprises generating at 808 a likelihood that the calculated change will result in a needle insertion that successfully engages the target.

In addition, the process 800 comprises transmitting at 810 a command to compensate for the calculated change to a delivery system that effectuates insertion of the needle where the generated likelihood exceeds a predetermined threshold, otherwise transmitting a command to stop the needle insertion operation before the needle breaches the live tissue. For instance, transmitting a command to compensate for the calculated change to a delivery system may comprise transmitting the command to stop if the generated likelihood that the calculated correction will result in a successful needle insertion is less than a predetermined percentage, e.g., 95%, 98%, etc. Transmitting the command to stop may also comprise transmitting a command to retract the needle to a default position.

Example Needle Insertion Device

Referring to FIG. 9, a partial cross-section illustrates select components of an example needle insertion device 900. The needle insertion device 900 can be used to implement the needle insertion device (see 106, FIG. 1). In this regard, the needle insertion device 900 can include any preceding described features, which will not be discussed for conciseness.

The needle insertion device 900 comprises a body that can function as a handle 902 that is maneuvered by the operator. The base of the handle 902 supports a patient contact component 904, which contains the probe (104 - FIG. 1), e.g., an ultrasound probe or other sensor(s). The handle 902 can also comprise a grip, motor, various electronics, buttons/controls, etc.

The needle insertion device 900 also includes an arm 906. The arm is controlled, e.g., via a motive drive mechanism, e.g., motor, actuator, etc., to exhibit angular motion, which can maneuver, pivot or otherwise reposition in at least one plane, e.g., X, Y, and Z planes. For instance, in an example embodiment, linear and angular position sensors are mounted directly on the arm 906 and this stage is used to control the delivery of the needle tip to within a±50um radius about the target depth. By way of example angular sensors and motor control algorithms can position the articulating arm 906 of the needle insertion device 900 to within ±0.005° unloaded, in air. As another example, linear sensors and motor control algorithms can position the stage to within ±10um unloaded and in air. By directly measuring the controlled portions of the system (arm angle and stage position), manufacturing tolerances, drive train slack and backlash, and component wear factors can be eliminated.

A cartridge 908, which includes a needle as schematically illustrated, traverses linearly along the arm 906 responsive to a drive system 910 contained within the arm 906. In operation, the needle insertion device 900 may include a tether, e.g., a wired or wireless connection that couples the ultrasound probe to an ultrasound device (e.g., imaging system 102 - FIG. 1). Once a target is selected via the imaging system 102, the needle insertion device 900 computes a needle insertion path, controls the motors to set the position of the arm 906 (e.g., by setting the angular orientation of the arm 906 relative to the handle 902, and controls the drive system 910 to traverse the needle cartridge along the arm toward the patient. For instance, the processor 132 (FIG. 1) can compute the desired arm angle and stroke length to perform a needle insertion operation based upon the selected target.

Dynamic Compensation bv the Needle Insertion Device

In example embodiments with dynamic compensation, the needle delivery system can dynamically determine if an altered angle of entry and/or distance of needle travel can“re-validate” a targeted structure and result in a successful needle deployment and entry into that structure. If such a solution can be found, needle delivery system will automatically alter the target within the structure and resulting motor control instructions (arm angle and stroke length) to successfully enter the structure. Such corrections can occur before actuation, during the time that the needle cartridge is advanced toward the patient, or even after the needle has penetrated the skin, but before the target is reached and the needle is stopped.

Changes in structure geometry due to changes in skin pressure at the needle insertion device/skin interface (e.g., caused by pressure at the patient contact component 904) can be caused by user hand motion and/or patient motion. As noted above, in example implementations for vessel access, in response to skin pressure changes, patient anatomical dynamics can cause a vein to compress or expand. This process is not necessarily symmetrical or predictable. The amount of compression or expansion can alter the size of the valid target envelope defined by the target boundary. Here, an example risk of concern is that structure compression occurs after the needle has been fired - the chance of missing the structure is significantly increased in this instance. Therefore, the needle insertion device 900 analyzes structure boundaries in real-time and stops needle travel when structure compression (and tissue compression above the structure) would result in an overshoot. If structure compression would cause the needle to fall short of the target point then, via micro motion, needle delivery system controlled via the drive system 910 can adjust the linear travel to move the needle into a new, smaller valid target solution envelope. This will be possible even if the system has reached the initially calculated (but no longer valid, due to structure compression) target point.

Relative motion can also cause changes in the position of the needle insertion device 900 relative to the selected target point without changing the shape or anatomical location of the selected structure. Uncorrected, this relative motion can also cause needle delivery system to miss the intended target point. If the relative movement occurs before needle deployment, real-time detection will quantify it, and dynamic compensation will attempt to compute a new angle and stroke to re-validate the target structure, or it will invalidate the current target position (while continuously acquiring fresh ultrasound images and recalculating to attempt to identify a valid target solution).

If movement occurs after the needle is deployed and enters the skin, dynamic compensation capabilities will be more limited, as the angle should no longer be changed. However, the needle insertion device 900 is capable of compensating for post-insertion movement along the axis of needle entry (or some vector component of movement along the Z-axis and/or Y -axis) because needle insertion device can perform linear needle distance changes at a micro-level via the drive system 910. This capability enables needle delivery system to reach a post-penetration valid target solution when possible, or to hold the position of the needle in the body in the presence of limited motion along the Z-axis or Y-axis, to the extent that the vector portion of that movement lies along the axis of needle entry.

In some embodiments, the needle insertion device 900 will resolve all movements into their respective X-, Y-, and Z-axis components, and then compensate by dynamically adjusting arm angle and stroke length. If the motion is of a magnitude that would not allow the needle to enter the targeted structure, the needle insertion device 900 will lock out the firing control and pause, continuing to analyze subsequent images and recalculating to determine if a valid target solution within the targeted structure can be found (and can message the user accordingly on the ultrasound screen). In an example implementation, if there is X-axis movement that invalidates the selected structure as a target, dynamic compensation will not be useful (the x-axis movement is orthogonal to the Y-Z plane in which the needle moves in this example). Instead, cues can be provided on the ultrasound display that aid the user in achieving a valid targeting solution.

In an example embodiment, a real-time go/no-go determination can be made in the presence of movement of the needle insertion device 900. The overall dynamic compensation scheme, which integrates major algorithm subsystems (sensor fusion, image processing & analysis, artificial intelligence and machine learning) into the operation of the trapezoidal solution, e.g., generated by a trapezoidal solution engine as the needle insertion device creates a GO-NO-GO output signal, provides a highly workable solution. For instance, in an example embodiment, the image processing and analysis processes interact with sensors (performing sensor fusion), the trapezoidal solution engine, and potentially artificial intelligence (where implemented) to carry out capabilities described more fully herein. Likewise, in example embodiments, the trapezoidal solution engine receives inputs from the image processing, sensor fusion, and optional artificial intelligence to derive a go/no-go command.

The trapezoidal solution engine may use only current and historical (causal) information to operate. However, over time through machine learning, predictions of future information (non-causal) based on current and historical information (causal) will increase the valid target solution space and potentially move first insertion success.

Miscellaneous Considerations

In select instances, it may not be possible to correct for a dynamic error source (hereinafter“uncorrectable dynamic error”). In instances where the delivery system is operated in conjunction with a sterile barrier, and the sterile barrier is broken, such an event may be considered an uncorrectable dynamic error. Also, frictional drag of the needle delivery system, uncontrolled wear in the drive system, and other such factors may result in uncorrectable dynamic errors. To minimize this risk, the drive system 910 of the needle insertion device 900 should be designed to generate enough force to allow the needle to traverse any sterile barrier kinks, folds or pinch points, the drag associated with material inconsistencies, and the energy expended to overcome them.

In addition, gross relative movement or targeted structure compression may not be correctable and may be designated as an uncorrectable dynamic error, which will likely result in termination of the process. Depending on which axis needs to be corrected for, correction may not be possible.

Generally, compensating for relatively large movements in the Z-axis is possible. For instance, in the example of vessel access, movement along the Z-axis away from the vessel will cause a loss of ultrasound image if skin contact is not maintained. Such motion is immediately apparent in the ultrasound image. Movement along the Z-axis toward the vessel will compress the vessel. Such motion and/or vessel boundary change can be detected and a warning can be communicated to the operator to reduce skin pressure.

It is also possible to compensate for some relative linear movement along the Y- axis, particularly if the operator is selecting a target in a“linear” zone of the targeted structure, e.g., a targeted blood vessel. In such a linear zone, the cross-section of the target used to calculate targeting may change very little with small movements along the Y-axis. Likewise, a“rocking” movement in which the probe position on the skin stays stable (via the patient contact component 904) but the upper portion of the needle insertion device 900, e.g., an upper portion of the arm 906, e.g., a grip, moves along the Y-axis can be compensated to some degree. Based on observations and lateral vessel views, pure Y-axis (in-and-out) motion appears to have impacts similar to those due to target compression/expansion, e.g., where the target is a vessel.

Generally, pure X-axis (side-to-side) linear motion and/or X-axis rocking in which the probe position on the skin stays stable should be rare with proper execution of aspects of the present disclosure. Moreover, X-axis movements are generally lower in tolerance compared to the Y and Z axis due to a likelihood of causing injury to tissue.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present disclosure has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the disclosure in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the disclosure Aspects of the disclosure were chosen and described in order to best explain the principles of the disclosure and the practical application, and to enable others of ordinary skill in the art to understand the disclosure for various embodiments with various modifications as are suited to the particular use contemplated.

Claims

CLAIMS What is claimed is:

1. A process for real-time compensation of needle path into tissue comprising:

detecting initiation of a needle insertion operation;

monitoring a condition associated with the detected needle insertion operation as the needle follows a first path toward a target point; and

performing a dynamic compensation modification where a change is detected in the monitored condition that deviates beyond a first predetermined threshold, comprising:

calculating a correction necessary to compensate the needle insertion operation based upon the detected change in the monitored condition;

generating a likelihood that the calculated correction will result in a successful needle insertion; and

transmitting a command to a delivery system that effectuates insertion of the needle based upon the calculated correction where the generated likelihood exceeds a second predetermined threshold, otherwise transmitting a command to stop the needle insertion operation before the needle breaches the tissue.

2. The process of claim 1, wherein monitoring a condition associated with the detected needle insertion operation as the needle follows a first path toward a target point comprises:

monitoring for a dynamic error source capable of altering the first path.

3. The process of claim 2, wherein monitoring for the dynamic error source capable of altering the first path comprises:

monitoring for rhythmic motion and/or transient motion by receiving movement data from a motion sensor coupled to the delivery system.

4. The process of claim 2, wherein monitoring for the dynamic error source capable of altering the first path comprises:

monitoring for patient respiration, changes in patient pulse, voluntary muscle movements, involuntary muscle movements, change in a physical dimension of the tissue, or a combination thereof by receiving movement data from a motion sensor coupled to the delivery system.

5. The process of claim 1, wherein detecting initiation of a needle insertion operation comprises:

receiving an initiation authorization from an operator of the delivery system.

6. The process of claim 5, wherein transmitting a command to a delivery system that effectuates insertion of the needle based upon the calculated correction where the generated likelihood exceeds a second predetermined threshold, otherwise transmitting a command to stop comprises:

transmitting the command to stop if the generated likelihood that the calculated correction will result in a successful needle insertion is less than 95%.

7. The process of claim 5, wherein transmitting the command to stop if the generated likelihood that the calculated correction will result in a successful needle insertion is less than 95% further comprises:

transmitting a command to retract the needle to a default position.

8. The process of claim 1, wherein calculating a correction necessary to compensate the needle insertion operation based upon the detected change in the monitored condition comprises:

calculating the correction based on a size of the target point, a shape of the target point, a travel path to the target point, an angle of the first path, or a combination thereof.

9. The process of claim 1 further comprising:

transmitting instructions to the delivery system that restricts an axis of movement for the needle once the needle breaches the tissue.

10. A process for real-time compensation of needle path into tissue comprising:

detecting initiation of a needle insertion operation, where the needle insertion operation is controlled based upon a needle insertion parameter;

detecting a change in a value associated with the needle insertion parameter after detecting the initiation of the needle insertion operation;

calculating a needle insertion compensation based upon the detected change; generating a likelihood that the calculated change will result in a needle insertion that successfully engages the target; and

transmitting a command to compensate for the calculated change to a delivery system that effectuates insertion of the needle where the generated likelihood exceeds a predetermined threshold, otherwise transmitting a command to stop the needle insertion operation before the needle breaches the live tissue.

11. The process of claim 10, wherein detecting a change in a value associated with the needle insertion parameter after detecting the initiation of the needle insertion operation comprises:

detecting a dynamic error source capable of altering the first path.

12. The process of claim 11, wherein detecting the dynamic error source capable of altering the first path comprises:

detecting rhythmic motion and/or transient motion by receiving movement data from motion sensors coupled to the delivery system.

13. The process of claim 11, detecting dynamic the error source capable of altering the first path comprises:

14. The process of claim 10, wherein transmitting a command to compensate for the calculated change to a delivery system that effectuates insertion of the needle where the generated likelihood exceeds a predetermined threshold, otherwise transmitting a command to stop the needle insertion operation before the needle breaches the tissue comprises:

15. The process of claim 14, wherein transmitting the command to stop if the generated likelihood that the calculated correction will result in a successful needle insertion is less than 95% further comprises:

transmitting a command to retract the needle to a default position.

16. A process for guiding a needle into a target point within tissue, comprising:

receiving information of an area of interest within tissue;

identifying a structure within the area of interest based on the received

information;

creating a target point within the identified structure for insertion by a needle, comprising:

identifying a boundary for the structure;

creating an eroded boundary within the identified boundary; and calculating a minimum needle depth and a maximum needle depth based on the eroded boundary, wherein the target point is established as a select point between the minimum needle depth and the maximum needle depth; and transmitting the created target point to a delivery system that effectuates insertion of the needle.

17. The process of claim 16, wherein calculating a minimum needle depth and a maximum needle depth based on the eroded boundary comprises: creating a target area, the target area based on projected needle paths that intersect an imaging plane within the eroded boundary, wherein the target area is positioned such that a distance along the imaging plane is equal at:

a most proximal point of the target area to the eroded boundary; and a most distal point of the target area to the eroded boundary;

wherein the target point is in between most proximal point and the most distal point along the imaging plane;

offsetting from the calculated target point, the distance along the imaging plane, in a direction to establish the minimum needle depth; and

offsetting from the calculated target point, the distance along the imaging plane, in an opposing direction to establish the maximum needle depth.

18. The process of claim 17, wherein:

calculating the target point within a target area, the target area based on projected needle paths that intersect an imaging plane within the eroded boundary comprises:

creating a trapezoidal bounding box using three needle paths; and transmitting the created target point to a delivery system that effectuates insertion of the needle comprises:

transmitting the created target point to a delivery system only when the created trapezoidal bounding box is entirely within the eroded boundary.

19. The process of claim 16, wherein creating an eroded boundary within the identified boundary comprises:

modifying the eroded boundary based on a needle gauge size of the needle and/or a bevel size of the needle.

20. The process of claim 16, wherein receiving positional information of an area of interest within tissue comprises:

receiving positional information of the area of interest via brightness-mode ultrasound, motion-mode ultrasound, color doppler ultrasound, power doppler ultrasound, directional power doppler ultrasound, pulsed wave doppler ultrasound, or a combination thereof.

21. The process of claim 16, wherein:

identifying a structure within the area of interest based on the received information, comprises identifying a vascular structure within the area of interest based on the received information; and

identifying a boundary for the structure comprises identifying a vessel boundary for the vascular structure.

22. The process of claim 21, wherein identifying a vascular structure within the area of interest further comprises discriminating between an artery and a vein within the tissue by: measuring deformation characteristics of the vascular structure;

designating the vascular structure as a vein if the deformation characteristics of the vascular structure exceed a pre-determined threshold; and/or

designating the vascular structure as an artery if the deformation characteristics of the vascular structure do not exceed the pre-determined threshold.

23. The process of claim 16, wherein:

identifying a structure within the area of interest based on the received information, comprises identifying a tumor mass structure within the area of interest based on the received information; and

identifying a boundary for the structure comprises identifying a tumor mass boundary for the tumor mass structure.

24. The process of claim 16, wherein:

identifying a structure within the area of interest based on the received information, comprises identifying a nerve structure within the area of interest based on the received information; and

identifying a boundary for the structure comprises identifying a nerve boundary for the nerve structure.

25. The process of claim 16, wherein:

identifying a structure within the area of interest based on the received information, comprises identifying an abscess structure within the area of interest based on the received information; and

identifying a boundary for the structure comprises identifying an abscess boundary for the abscess structure.

26. The process of claim 16, wherein:

creating a target point within the identified structure for insertion by a needle, comprises creating a target point suitable for tissue extraction.

27. The process of claim 16, wherein:

creating a target point within the identified structure for insertion by a needle, comprises creating a target point suitable for fluid delivery.

28. The process of claim 16, wherein:

creating a target point within the identified structure for insertion by a needle, comprises creating a target point suitable for energy delivery.