A device for inserting a penetrating member into tissue along the insertion axis.

Abstract

An automated insertion device and method for use are provided. A vibrator and a stretcher are connected to the penetrating member, both in electrical communication with a controller. A detector identifies a subcutaneous target for insertion and an insertion angle. The distance and trajectory of the penetrating member are calculated. The vibrator applies vibrations to the penetrating member, and the stretcher advances the penetrating member for insertion. The vibrator and stretcher are in electrical communication with each other during the insertion process, and adjustments to the insertion speed are made based on feedback of the vibration load encountered by the vibrator during insertion, and adjustments to the vibration are made based on feedback of the insertion load experienced by the stretcher during insertion. Repeated samples are taken, and operation of one motor is constantly adjusted based on operation of the other motor and feedback from the other motor.

Description

[Technical Field] 【0001】 This application is a continuation-in-part application of the concurrently pending U.S. application No. 15 / 267,801, filed on 16 September 2016, claiming the interests of U.S. provisional application No. 62 / 220,567, which was filed on 18 September 2015 and is now expired, and the entire contents of the former are incorporated herein by reference. 【0002】 The present invention generally relates to devices for penetrating tissues within the body by automated means for the delivery or removal of bodily fluids, tissues, nutrients, pharmaceuticals, and therapeutic agents, and for obtaining percutaneous access to body compartments (e.g., the vascular system, spinal canal, etc.) for the secondary placement of medical devices (e.g., guidewires, catheters, etc.). [Background technology] 【0003】 Central venous catheters (CVCs) provide access to the central circulation of medical patients. More than 5 million CVCs are placed annually in the United States. CVCs are a vital platform for initiating numerous critical medical interventions for patients with acute illnesses and those requiring major surgery or procedures. More than 15 million CVC days are used annually in intensive care units (ICUs) alone in US hospitals, and 48% of ICU patients have a CVC inserted at some point during their ICU stay. CVCs are also necessary for patients requiring emergency hemodialysis, including for acute renal failure, plasmapheresis for various immune-mediated diseases, multiple forms of chemotherapy for cancer patients, parenteral nutrition for patients unable to use their gastrointestinal tract for nutrition, and many other medical interventions. 【0004】 Since the 1950s, CVC placement has been performed using the technique of the same name, developed by Swedish radiologist Sven-Ivar Seldinger. This technique involves advancing a hollow needle, also called an introduction needle, through the patient's skin and subcutaneous tissue, eventually reaching a central vein located a few millimeters to a few centimeters below the skin surface. The "central veins" are the internal jugular vein, subclavian vein, and femoral vein. Once in the central vein, a wire is manually placed through the hollow needle into the vein. The needle is then removed, and often a plastic coaxial tissue dilator is passed over the wire and then removed from the wire. This stretches the tissue around the wire, allowing the CVC to pass through smoothly, and it is then placed on the wire and inserted into the vein. Once the CVC is in place, the wire is removed, and the CVC can be left in the vein. 【0005】 Since the Seldinger technique was first described, the standard guide for where to place the introduction needle through the skin has been the patient's surface anatomy. Veins are typically located a few millimeters to a few centimeters below the skin and have specific relationships with certain surface landmarks such as bone and muscle. However, the failure rate of CVC placement and the incidence of serious complications such as arterial puncture, laceration, pneumothorax, or "lung collapse" using surface anatomy have been reported in respected studies as 35% and 21%, respectively. These failure rates are due to the fact that surface anatomy cannot reliably predict the location of the deep central vein in all patients. In 1986, ultrasonography (US) was used to visualize veins beneath the skin surface and to more accurately guide the manual placement of CVCs using such images. The use of this technique reduced the failure rate and complication rate of CVC placement to 5-10%. However, sufficient training and experience are necessary to reliably perform the ultrasound-guided CVC placement technique. For this reason, general surgeons and cardiovascular surgeons, anesthesiologists, emergency medicine specialists, and interventional radiologists are usually the ones who should be placing these catheters. Unfortunately, these specialists are often unable to respond to the urgent or critical timeframes that are frequently required for CVC deployment. 【0006】 Even well-trained and experienced providers can fail at CVC placement at the same rate due to factors beyond their explanation or control, given the current state of insertion techniques. Two major factors are tissue deformation and vein wall deformation. As the insertion needle is pushed into the skin and subcutaneous tissue, the force can cause the target of the central vein to shift from its original position, resulting in a so-called "missed needle passage." Once the needle reaches the vein wall, it can push the vein to another position, a phenomenon called "rolling," again causing a missed needle passage. A missed needle passage can result in the needle striking important structures near the central vein, such as arteries, lungs, or nerves, potentially leading to serious complications. The vein wall can also be compressed by the force of the needle, causing the vein to collapse and making it nearly impossible to enter the lumen, and usually facilitating the needle to pass through the posterior wall of the vessel. This is a phenomenon called a "venous blow." A venous blow usually causes bleeding into the perivenous tissue. Bleeding is not only a significant complication in itself, but it also disrupts the local anatomical structure, usually hindering the success of subsequent CVC placement. 【0007】 Therefore, there is interest in various alternative systems for CVC placement, including automated systems that can be operated by clinicians or healthcare professionals. Such systems could enable more widely available, reliable, and rapid CVC placement while reducing the potential for complications. However, to date, most research has focused on maneuverable needles to address the fundamental challenges of tissue and vascular deformation. Yet, no satisfactory automated CVC placement system has been developed. [Overview of the project] 【0008】 An automated insertion device, system, and method are disclosed that combines operational position guidance for target placement with vibration of a penetrating member, such as a needle, to penetrate the skin, subcutaneous tissue, and vein walls, mitigating the problem of tissue and vascular wall deformation that poses a challenge to needle insertion. The device and system includes a series of mechanical actuators that direct the path of the penetrating member or needle according to a processor that calculates and directs the positioning and path of the needle placement. Various actuators can be automated to operate according to the instructions of the processor. Although described as being used for the automated insertion of penetrating members such as needles, the same device and system can be used to insert additional medical devices, including guidewires and catheters, into any body cavity, blood vessel, or compartment. 【0009】 The insertion device employs the use of a specific vibrating penetration member. Previous studies have demonstrated that vibrating the needle during insertion reduces both puncture force and frictional force. This phenomenon is utilized in nature when mosquitoes vibrate their proboscis to penetrate the host's skin. The increased needle velocity due to vibration reduces tissue deformation, energy absorption, penetration force, and tissue damage. Some of these effects are due to the viscoelastic properties of biological tissues and can be understood through a modified nonlinear Kelvin model that captures the force deformation response of soft tissues. Since the deformation of the internal tissue of a viscoelastic material is velocity-dependent, increasing the needle insertion speed reduces tissue deformation. When tissue deformation is reduced before a crack propagates, the rate at which energy is released from the crack increases, ultimately reducing the force of rupture. The reduction in force and tissue deformation due to increased needle insertion speed is particularly pronounced in tissues with high water content, such as soft tissues. In addition to reducing the force associated with cutting tissue, studies have also shown that vibration of the needle during insertion reduces the frictional force between the needle and the surrounding tissue. 【0010】 Therefore, applying vibrating motion, also referred to herein as vibration and / or reciprocating motion, to the needle during insertion overcomes three challenges in advancing the needle tip to the desired position compared to the use of a static needle. First, vibration minimizes tissue deformation between the skin and the target vein. This tissue deformation, along with the "pop-through" that occurs when the needle tip crosses different tissue layers, can cause the target to move away from the needle's planned path. Second, a vibrating needle reduces rolling of the target vein. Third, a vibrating needle provides additional contrast to the ultrasound image, allowing the user to observe the advancing needle and its final placement. Imaging modes that are particularly sensitive to changes in velocity, such as ultrasound with color Doppler overlay, are particularly sensitive to detecting a vibrating needle. 【0011】 This system also provides a method for changing the target point before deploying the penetration member. When the target point is changed, the processor recalculates and updates the position information of the penetration member and provides updated adjustment data for various actuators to align the penetration member to the new target point. Imaging can be used with the insertion device to visualize images of the subcutaneous region for the user to view. The target point can be selected and updated on the display by the user for interactive control. 【0012】 The insertion device may also be handheld to facilitate use by the practitioner or user. In certain embodiments, the automated insertion device includes a vibration assembly and a stretching assembly that communicate with each other and / or with a control unit or processor. The vibration assembly includes a vibration actuator that generates axial vibrations when in operation and transmits or gives these vibrations to a connected penetration member. The stretching assembly includes a stretching actuator directly or indirectly connected to the penetration member, which moves the penetration member along the insertion axis to insert the penetration member into a desired pre-selected target in the target tissue. The insertion distance may be calculated or determined by the control unit or processor based on image data from a detector, such as an ultrasonic probe, positioned to detect the subcutaneous target site and provide visualization or three-dimensional coordinates of the target site. The insertion angle of the penetration member may also be adjusted based on target information and / or image data from which the target information is derived. 【0013】 During operation, the vibration actuator vibrates the through member axially according to the actuator's operating parameters. While vibration is occurring, the extension actuator advances the through member along the insertion axis by a determined distance to reach the target site. By default, the vibration actuator and extension actuator operate in their respective initial modes. During insertion, the loads on the vibration actuator and extension actuator are monitored at intervals such as every few milliseconds. If the load and / or power consumption of the vibration actuator or extension actuator changes by a predetermined value, a control signal can be sent to the other actuator to change its operating parameters and compensate. For example, the extension actuator may adopt a different operating mode, such as increasing or decreasing the insertion speed, depending on the load on the vibration actuator. Similarly, a control signal can be sent to the vibration actuator to change vibration parameters such as vibration power, amplitude, and / or frequency, allowing it to adopt a different vibration mode with higher or lower power, amplitude, or frequency, depending on the load on the extension actuator. If further deviations occur from predetermined values ​​in the load and / or power consumption of the vibration actuator and / or extension actuator, additional signals may be sent to the extension actuator and / or vibration actuator to further adjust the insertion speed and / or vibration. This may be an increase or decrease in one motor or actuator, compensating for a decrease or increase in the other motor or actuator, respectively. Each determination of whether the deviation in the load and / or power consumption of the vibration actuator or extension actuator exceeds its respective predetermined value may be based on or compared to the most recently detected load and / or power consumption level, or the initial starting load and / or power consumption level of each actuator. 【0014】 Therefore, a number of insertion speeds and operating modes may exist, which are automatically adjusted throughout the insertion process in response to the load and / or power consumption of the vibration and / or extension actuators. The vibration and extension actuators operate collectively, responsively, and automatically to adjust their operating parameters during insertion in response to what the other actuators are experiencing, in order to achieve the most effective and efficient insertion of the penetrating member into the subcutaneous target. This avoids the tissue deformation problem that previously plagued practitioners. 【0015】 Thus, the insertion speed and vibration rate are not constant throughout the insertion process. Rather, the speed can be increased or decreased based on input from other motors. If one motor "stops working" (for example, if it is consuming more power than predetermined as a result of excessive resistance during tissue penetration), the other motors adjust and compensate. For example, if the vibration actuator is vibrating with a reduced amplitude, the insertion speed of the stretch actuator can be reduced. Conversely, if the penetration member is vibrating without problems, the stretch actuator may operate at the maximum insertion speed. The vibration can also be adjusted based on the operation of the stretch actuator. If the stretch actuator begins to consume excessive power, it indicates that it is encountering excessive resistance during tissue penetration, and this input is transmitted to the vibration actuator, triggering a change to a more aggressive vibration mode to assist in penetration of denser tissue. This communication between the stretch actuator and the vibration actuator is bidirectional, whether it occurs directly or indirectly via the processor. 【0016】 The insertion apparatus and method, along with their specific features and advantages, will become clearer by referring to the detailed description and accompanying drawings below. [Brief explanation of the drawing] 【0017】 [Figure 1] This is a perspective view of one embodiment of the insertion device of the present invention. [Figure 2]It is a side view of the insertion device in FIG. 1 and a schematic diagram of the arrangement for use. [Figure 3] It is a schematic diagram of a system for inserting a penetrating member. [Figure 4A] It is a side view of the insertion device in FIG. 2 showing the adjustment of the handle. [Figure 4B] It is a plan view of the insertion device in FIG. 2 showing the adjustment of the side arm for positioning. [Figure 5A] It is a schematic diagram of the insertion device showing the dimensions used for calculations by the processor. [Figure 5B] It is a schematic diagram showing the target area used for calculations by the processor. [Figure 5C] It is an exemplary ultrasonic display used when visually adjusting the insertion device. [Figure 6] It is a side view of the insertion device in FIG. 1 and shows a schematic diagram of various adjustments instructed by the processor for automatic insertion. [Figure 7] It is a perspective view of the insertion device in FIG. 6, partially cut away, showing various actuators. [Figure 8A] It is a side view showing the vertical adjustment by the vertical actuator. [Figure 8B] It is a side view showing the vertical adjustment by the vertical actuator. [Figure 9] It is a partial cutaway view showing one embodiment of the vertical actuator for vertical adjustment. [Figure 10] It is a side view showing the angular adjustment by the angular actuator. [Figure 11] It is a partial cutaway view showing one embodiment of the angular actuator for angular adjustment. [Figure 12A] It is an exploded view of a part of the insertion device having an angular actuator, showing the key relationship of the angular actuators from opposite directions. [Figure 12B] It is an exploded view of a part of the insertion device having an angular actuator, showing the key relationship of the angular actuators from opposite directions. [Figure 13]This is a side view showing the adjustment by linear extension. [Figure 14] This is a partial breakaway view showing one embodiment of a stretch actuator for extension. [Figure 15A] This is a top view of a partial cross-section showing the extension actuator and connected extension shaft in the retracted position. [Figure 15B] Figure 15A is a top view of a partial cross-section showing the extension actuator and connected extension shaft in the extended position. [Figure 16A] This is a partial breakaway view showing one embodiment of a vibration actuator for vibrational motion. [Figure 16B] This is a cross-sectional view of one embodiment of a vibration actuator for vibration motion. [Figure 17] This is a perspective view of another embodiment of an insertion device including an insertion guide wire. [Figure 18A] This is a partially broken perspective view of an embodiment of Figure 17, showing a guide wire actuator for guide wire placement. [Figure 18B] Figure 17 is a perspective view showing a portion of the embodiment, illustrating the positioning of the guide wire passing through the insertion device. [Figure 19A] This is a perspective view of one embodiment of the example shown in Figure 17, illustrating the mounted guide wire housing. [Figure 19B] This is an exploded view of the embodiment shown in Figure 19A, which illustrates the removed guide wire housing. [Figure 20A] This is a perspective view of another embodiment of an insertion device, in which reciprocating and vibrating actuators are arranged in a line with a through member. [Figure 20B] This is a partial cross-sectional view of the embodiment of Figure 20A, showing a guide wire passing through a vibration actuator. [Figure 20C] This figure shows a close-up of the cross-section in Figure 20B. [Figure 21A] A perspective view of one embodiment of an inline housing with side ports is shown. [Figure 21B] This is a cross-sectional view of the embodiment shown in Figure 21A. [Figure 22] This figure shows another embodiment of a neck having multiple side ports. [Figure 23] This is a perspective view of another embodiment of the automatic insertion device of the present invention, shown in the retracted position. [Figure 24] Figure 23 is a perspective view of the insertion device, shown in the extended position. [Figure 25] Figure 23 is a perspective view of the insertion device, showing the proximal end of the device. [Figure 26] This is a schematic diagram of one embodiment of an automatic insertion device that demonstrates the interconnection operation between an extension assembly and a vibration assembly. [Figure 27] This is an electrical flow diagram illustrating one embodiment of the device's operation. [Figure 28] This is a schematic diagram of the steps for operating an automatic insertion device. 【0018】 Throughout several figures in the drawing, similar reference numbers refer to the same parts. [Modes for carrying out the invention] 【0019】 As shown in the accompanying drawings, the present invention relates to an insertion device, system, and method for enabling subcutaneous access to a body cavity, such as a blood vessel, for inserting a needle and potentially positioning a guidewire, dilator, catheter, or other device. The device and system include a plurality of actuators that can be automated to adjust position and deploy a penetrating member into the target tissue, such as the patient's skin. A target point is pre-selected and used to calculate the position and alignment of the penetrating member, and a series of actuators are adjusted to control various components of the device to generate appropriate alignment so that it reaches the pre-selected target position upon deployment. The actuators may be automatically adjusted based on calculations made by a processor and may be further adjusted if the position of the target point changes. In at least one embodiment, an image-based modality is used to acquire data about the target tissue or cavity. For ease of use, it is desirable that the entire device be handheld. 【0020】 An insertion device 100, as shown in the embodiments of Figures 1 and 2, includes a detector 20 for acquiring data and information about subcutaneous tissue, and a processor 22 for using this data to calculate various positioning and adjustment parameters for a penetrating member 10, which may be an introduction needle, for insertion into a desired pre-selected target point 29 in the tissue, based on calculated parameters. The target point 29 may be any point located subcutaneously within the patient's body, such as a blood vessel. Identifying a target blood vessel is a typical skill for many medical professionals trained in the medical industry. However, guiding the needle to that target is difficult given the complications and risks to the patient from tissue deformation and venous rolling. 【0021】 In at least one embodiment, the insertion device 100 allows the user to acquire information about a target vessel in the tissue through an imaging modality such as ultrasound and select a target point 29 on a display 24 showing a corresponding image of the vessel. The target point 29 can be adjusted by the user on the display 24, such as on a touchscreen, and the processor 22 automatically calculates the resulting height, trajectory, angle, and distance that the tip of the penetrating member must move from its current position to reach the target location in the patient's body. Using these calculations, the processor 22 provides motion data or commands to various actuators 32, 42, 52 of the positioning device 120 to move the tip of the penetrating member 10 in various directions in an automated manner to reach a desired position ready for deployment. Each actuator 32, 42, 52 may include a sensor that transmits position information used when performing adjustment calculations to the processor 20. Once the desired position is achieved, the device 100 can be activated to deploy the penetrating member 10 and advance it by the calculated distance. The processor 22 can also instruct the penetrating member 10 to automatically stop when it reaches a pre-selected target point 29, thereby preventing the penetrating member 10 from passing the target point 29. The processor can also instruct the vibrating actuator 62 to initiate and guide the penetrating member 10 into vibrating motion, such as reciprocating motion, during deployment to overcome tissue deformation and venous rolling complications typically encountered during needle insertion. 【0022】 As shown in Figure 3, the insertion device 100 also includes a system 200 in which information or data representing subsurface tissue, including cavities such as blood vessels, is obtained by a detector 20. In some embodiments, this data is an image obtained by the detector 20, which may be an image detector. The data of the subsurface tissue is transmitted to a processor 22, which calculates the distance between a pre-selected target point 29 in the tissue or cavity and the tissue surface. The computing software, logic circuits, etc., of the processor 22 use this calculated distance to calculate adjustment data for the vertical actuator 32, the angle actuator 42, and the extension actuator 52, and transmits this data to the corresponding actuators for the movement of the penetration member 10. The processor 22 also determines vibration data for the vibrating actuator 62 based on the operating parameters of the vibrating actuator 62, transmits this data to the vibrating actuator 62 to activate it, and induces vibration or reciprocating motion in the penetration member 10 to unfold. The transmission of data to the various actuators 32, 42, 52, 62 and their activation can occur in any order, or in a predetermined or specified order, as indicated by the processor 22. The through member 10 can be automatically deployed based on stretch adjustment data transmitted to the stretch actuator 52. In some embodiments, the user can determine when the through member 10 has reached the correct position to align with a projected path intersecting a target point 29, and he / she can activate a deployment command which is transmitted to the processor 22 and relayed to the stretch actuator 52 to stretch the through member 10 by a pre-calculated distance to the target point 29 under the skin based on information from the obtained image. 【0023】 In some embodiments, the detector 20 is an image detector such as an ultrasonic probe or other transceiver. The data obtained by the detector 20 can be presented on a display 24 that can be viewed by the user. A representation of a pre-selected target point 29' is superimposed on the image presented on the display 24 and can be moved by the user. In at least one embodiment, the user can move a representative target point 29' on the display 24 by interacting with the image or representation on the display 24 via an interactive touchscreen or joystick, etc. As the representative target point 29' moves on the display 24, the processor 22 calculates updated adjustment data for the vertical actuator 32, the angle actuator 42, and the extension actuator 52 based on the new representative target point 29'. This can be done any number of times before the final target point is determined by the user, at which point the user can decide to unfold the through member 10 for insertion, and a corresponding command is sent to the extension actuator 52. 【0024】 During use, the insertion device 100 is positioned along or adjacent to the patient's tissue, such as skin, to locate a target vessel, such as a vein. In at least one embodiment, as shown in Figures 1 and 2, the device 100 is handheld and includes a handle 21 that can be gripped by a user, such as a clinician or medical professional. The handle 21 can be ergonomically shaped to improve efficiency and comfort, especially when held for extended periods as needed. The handle 21 is preferably gripped by the user's non-dominant hand, such as the left hand of a right-handed person, so that the dominant hand can be used for selecting the target position and deploying the device 100. Thus, the device 100 can be used equally by right-handed and left-handed individuals and is not specific to the direction of grip. In fact, in some embodiments, the handle 21 is rotatable around an axis, as shown in Figure 4A, to accommodate different grip orientations or positions, or to obtain different image figures during imaging. 【0025】 In at least one embodiment, the insertion device 100 also includes a support 27 which can be positioned on the user's elbow, shoulder, arm, or chest. The support 27 provides additional stability to the user when positioning and using the device 100. As shown in Figure 4B, the support 27 may be spaced away from the handle 21 by a side arm 26 corresponding to the user's arm, and may be adjustable in length to be within reach of the user. The side arm 26 may be movable within an arc-shaped path, adjusting its angle and positioning appropriately as needed to target a blood vessel, as indicated by the directional arrows in Figure 4B, to allow the user positioned next to the patient to comfortably use the insertion device 100. The range of motion of the side arm 26 is up to 360° and can therefore accommodate any desired approach angle. For example, the user may sit or stand adjacent to the patient perpendicular to the desired target blood vessel, yet still be able to use the insertion device 100 to align and position the penetrating member 10 with the target blood vessel. The full range of motion of the side arm 26 makes it possible to switch between right-handed and left-handed use. 【0026】 The insertion device 100 includes a detector 20 that is near, adjacent to, or even in contact with the patient's area to be imaged, as shown in Figure 2. In at least one embodiment, the detector 20 is positioned at the end of a handle 21 so that the detector 20 can be positioned along the patient's skin or other tissue 5 by moving the handle 21 over the patient. The detector 20 acquires information or data about the surrounding area, such as a subcutaneous region, and may include location information of tissue 5, cavities 7, and other structures within them. In at least one embodiment, the detector 20 is part of an imaging modality that visualizes a subcutaneous or transcutaneous region of the patient, also called a target region 28, as shown in Figure 5B, to target a specific blood vessel or body cavity 7. The imaged target region 28 may be of any shape, volume, or depth D so as to enable a particular imaging modality to be generated. The imaging modality may be any suitable form for imaging a subcutaneous region of the patient, including but not limited to ultrasound, computed tomography, and magnetic resonance imaging. In a preferred embodiment, as shown in Figure 5C, ultrasound is useful for its ability to provide images that clearly distinguish tissue 5 from body cavities 7, such as the inside of blood vessels beneath the surface of the skin. As used herein, “tissue” may refer to any tissue or organ of the body, specifically substantial material having mass. For example, tissue may refer equally to skin, muscle, tendon, fat, bone, and organ walls. In contrast, as used herein, “body cavities” may refer to the volume of cavities, open interiors, lumens, or spaces within tissue or organs, such as blood vessels, veins, and arteries. 【0027】 Therefore, in at least one embodiment, the detector 20 is an ultrasound transducer that emits and receives ultrasound through the patient's skin and tissues for visualization. Typical B-mode ultrasound imaging can be used with the detector 20, but Doppler ultrasound can also be used to distinguish blood flow in different directions. In some embodiments, a sector-phased array can be used, but linear or curved ultrasound transducers are preferred. The ultrasound detector 20 can operate in the frequency range of 3 to 15 MHz, but more preferably in the range of 6 to 10 MHz to provide a good contrast between ultrasound resolution and penetration depth, as penetration depth is inversely proportional to frequency. Very accurate measurement of pixel size is important for accurately positioning the penetrating member 10, as pixel size is related to the distance or phase velocity of sound within the tissue. The ultrasound detector 20 can be operated in a long-axis plan view where blood vessels are seen longitudinally, or in a short-axis view where blood vessels are seen in cross-section and appear as a circular structure in the resulting image as shown in Figure 5C. In at least one embodiment, imaging in a short-axis view is preferred to better visualize the body cavity 7, which appears as a black space against the tissue 5 shown in white. The short-axis view allows us to see the depth of the blood vessel in order to determine the optimal placement of the target point 29 so as not to blow away the vein or blood vessel. In either diagram, the image plane generated by the detector 20 is at a known angle to the various actuators described later for proper positioning accuracy and alignment between the ultrasonic image and the spatial coordinates of the penetrating member 10. 【0028】 The insertion device 100 further includes a processor 22 that electronically communicates with the detector 20 and receives data obtained by the detector 20 regarding the location of the tissue 5 and the cavity 7 within it. In some embodiments, this data is arranged as an image of the subcutaneous region obtained by the detector 20 and transmitted to the processor 22 and a display 24 (such as a screen that presents the image for user visualization, as shown in Figures 1 and 2). Figure 5C shows an example of an ultrasound image acquired by the detector 20 presented on the display 24. The display 24 also shows a pictorial representation of the target point 29' using crosshairs, target markers, or other symbols in relation to the image from the detector 20. The image of the representative target point 29' on the display 24 may be moved up and down on the display 24 by the user. As the representative target point 29' moves, the positioning of the penetration member 10 is adjusted as described below, which may be done automatically and in real time. The display 24 may display additional information including, but not limited to, parameters of the detector 20 (such as the frequency used), screen resolution, magnification, measurements or positional information from various components of the positioning device 120 (discussed in more detail below), and buttons or areas for activating various components of the insertion device 100. 【0029】 The display 24 may be a passive screen or an interactive screen. In at least one embodiment, the display 24 is a touchscreen that can operate through a resistive mechanism, a capacitive mechanism, or other haptic feedback mechanism. For example, a representative target point 29' on the display 24 may be movable by touching the touchscreen, such as by sliding a finger, thumb, or selection device along the display 24 in a continuous path, or by touching discrete locations on the display 24 screen to select a new position for the representative target point 29'. In some embodiments, the display 24 and processor 22 may be included in a single device such as a smartphone, personal digital assistant (PDA), or tablet computer, which may be detachably connected to the insertion device 100 via a wireless protocol such as Bluetooth® or via a wired multi-pin connector. In other embodiments, the display 24 and processor 22 may be included in a single device that may be integrated with the rest of the insertion device 100. In further embodiments, the processor 22 may be an integrated component of the insertion device 100 and may be located within the housing 23 as shown in Figure 1, and the display 24 may be separately removable from the rest of the insertion device 100. 【0030】 In other embodiments, the display 24 is a passive screen such as a monitor, and the apparatus 100 may include a joystick or directional buttons (not shown) that allow the user to guide the imaging assembly 110 to target a vein. The joystick or directional buttons can output a directional signal to the processor 22 based on the orientation and tilt of the joystick lever, or a specific directional button that is pressed or selected. The output signal from the joystick or directional buttons controls the position of a representative target point 29', such as a crosshair shown on the display 24, so that the image of the target point 29 overlaps the target position. In some embodiments, the joystick or directional buttons may be located on or near the display 24, such as along the edge of the monitor frame. In other embodiments, the joystick or directional buttons may be located on the handle 21 to allow one-handed operation of the apparatus 100 for imaging. 【0031】 The processor 22 electrically communicates with the display 24 regarding the position and changes in the position of a desired target point 29, as indicated by the user through interaction with a representative target point 29' on the display 24, such as through touchscreen interaction, and receives information from the display 24. The processor 22 includes a program, software, logic circuit, or other computing power to calculate a method for adjusting the through member 10 from its existing position to a position that reaches the target point 29 indicated by user-instructed information provided from the display 24 interaction. 【0032】 For example, Figure 5A shows a schematic diagram of the insertion device 100, illustrating various dimensions used in calculations by the processor 22. Some of these dimensions are fixed dimensions of the device 100. For example, H is the height of the handle 21 from the detector 20 to the center of the main arm 25. Distance A is the length of the main arm 25 from the center of the handle 21 to the center of a positioning device 120, such as a vertical actuator 32. In some embodiments, A is a fixed length, such as when the primary arm 25 is a fixed length. The size of the mounting portion of the through member 10 and the length of the puncture tip 10, such as a needle (collectively referred to as G) are also known and fixed. The distance F between the mounting portion of the through member 10 and the angle adjuster 30 remains fixed. 【0033】 Other dimensions of the calculation are different. For example, D is the distance between the detector 20 located on the surface of tissue 5 or skin and the target point 29 in a body cavity 7, such as inside a blood vessel beneath the skin. Thus, D will vary from patient to patient depending on which blood vessel is used as the target, the amount of tissue present between the target vessel and the skin or surface where the detector 20 is located, as well as the location of the target vessel and the degree of vascular filling or compression. In at least one embodiment, the height L of the positioning device 120 may vary. In some embodiments, the height L in Figure 5A can be preset before use so that it is fixed when the insertion device 100 is used. Using this information, the microprocessor uses the Pythagorean theorem and trigonometry to determine the inclination angle θ D This allows us to determine the distance P from the tip of the penetrating member 10 to the target point 29. For example, the calculation can be performed as follows. 【0034】 【number】 【0035】 Alternatively, angle θ D The user can pre-set the parameters, and the height L and distance P can also be calculated using a similar mathematical relationship. Looking at it another way, and again referring to FIG. 5A, depth D forms one side of a triangle, distance X is the distance from the center of detector 20 to the tip of penetration member 10, and D forms a right angle with another leg of the triangle. The insertion distance of penetration member 10 is P, which is the hypotenuse of the triangle, and is calculated by solving the following equation for P. D 2 + X 2 = P 2 Therefore, the insertion angle θ D is calculated as follows. 【0036】 【Equation】 【0037】 Therefore, there are many ways to perform calculations based on known constant dimensions and variables. The above is just one example. In other embodiments, height L can be adjusted and automated during use of insertion device 100, such as when a shallow angle or acute angle θ D is required. This applies when the target blood vessel itself is very shallow or partially collapsed, or is below the surface of the skin. In such an exemplary embodiment, to achieve an appropriate angle, height L can be increased and penetration member 10 can be positioned to reach target point 29. The amount of increase or decrease in height L is calculated in real time by the processor of processor 22. Angle θ D is also calculated for adjustment based on information input by the user on display 24. For example, when the user slides a finger up along display 24, the target point 29 indicator also moves up, and angle θ D becomes shallower or sharper. Conversely, when the user slides a finger down along display 24, the target point 29 indicator also moves down, and angle θ DThe angle increases or deepens. Sliding a finger along the touchscreen display 24 is just one embodiment. In other embodiments, a knob or dial can be used to move a representative target point 29' up and down on the screen, at an angle θ determined by the processor 22. D It will be adjusted accordingly. 【0038】 The processor 22 also communicates electronically with a positioning device 120, which is spaced apart from the imaging assembly 110 of the insertion device 100, via a main arm 25 or the like. The main arm 25 can be any suitable length sufficient to space the through member 10 away from the detector 20 so that the through member 10 can approach and reach a desired target point 29. The main arm 25 is adjustable manually or automatically by an actuator or the like, but in at least one embodiment, it is stationary and has a fixed length. 【0039】 Referring to Figures 1, 2, and 6, the positioning device 120 includes a vertical adjuster 30 for adjusting the through member 10 in the vertical direction 31, an angle adjuster 40 for adjusting the inclination angle of the through member 10 along the angular direction 41, and an extension adjuster 50 for moving the through member toward or away from the target point 29 in the linear direction 51 for insertion and removal. A vibrator 60 that provides reciprocating motion along the through member 10 in the longitudinal direction 61 is also present in the insertion device 100, but does not need to be a component of the positioning device 120. As seen in Figure 7, each of the adjustment parameters is affected by actuators 32, 42, 52, and 62, which receive signals from a processor 22 that provides commands regarding the movement parameters and can automatically move according to those commands to adjust the positioning of the through member 10. 【0040】 For example, referring to Figures 7 to 9, the vertical adjustment 30 provides a mechanism for raising and lowering the mounted through member 10. Specifically, the vertical adjustment 30 includes a vertical actuator 32 that communicates with a processor 22 to receive vertical adjustment data for activation and movement. Upon receiving a signal or data from the processor 22, the vertical actuator 32 operates and moves according to the vertical adjustment data calculated by the processor 22 to adjust the through member 10 perpendicular to the surface of the skin or other tissue to be imaged for insertion 31. The vertical actuator 32 may be a motor that rotates or acts on a shaft. For example, in at least one embodiment, as shown in Figure 9, the vertical actuator 32 is a rotary motor that rotates a pin 35 extending from the vertical actuator 32. The pin 35 engages with the track 34 in an interlock manner between corresponding teeth or grooves on the pin 35 and the track 34, such as in a rack and pinion system. As the pin 35 rotates in one direction, its extension engages with the extension of the track 34, moving the track 34 up and down in the vertical direction 31. When the vertical actuator 32 rotates the pin 35 in the opposite direction, the track 34 moves correspondingly in the opposite vertical direction. Thus, the vertical actuator 32 can be positioned perpendicular to the track 34. The track 34 can be positioned within the vertical housing 33. In other embodiments, the track 34 may be a slide bar, and the vertical actuator 32 may move the slide bar vertically by moving the pin 35 along the slide bar between different locking positions. In yet another embodiment, the vertical actuator 32 may be a linear motor positioned along the vertical direction 31, which, when actuated, extends the pin 35 or other elongated shaft, thereby moving the housing 33 along the vertical direction 31. As described above, in some embodiments, the vertical actuator 32 can be automated by the processor 22 and move in real time as adjustments are made to the target point 29 on the display 24. However, in some embodiments, the vertical actuator 32 may not be actuated, for example, when adjustment of the vertical direction 31 is not required, or when it is intended to fix the vertical height component. 【0041】 The positioning device 120 also includes an angle adjustment 40, as shown in Figures 7 and 10-12B. The angle adjustment 40 includes an angle actuator 42 that telecommunicates with the processor 22. The angle actuator 42 receives signals from the processor 22, such as angle adjustment data, and provides commands for operation to change the inclination angle of the penetration member 10. The inclination angle can be any angle between 0° and 180° with respect to the surface of the tissue. In at least one embodiment, the inclination angle is an acute angle between 0° and 90°. The inclination angle is adjusted in the angular direction 41 as seen in Figure 10, according to calculations performed by the processor 22. Thus, the penetration angle can be shallow or steep as determined by the user. In the imaging embodiment, when the user moves a representative target point 29' up and down on the display 24, a corresponding signal is relayed from the processor 22, and the processor 22 updates its calculations to determine updated or new angle adjustment data based on the new position of the representative target point 29'. This updated data is transmitted to the angle actuator 42, which activates to adjust the angle of the through member 10 accordingly, which may be in real time. This activation is automated by the processor 22. The angle actuator 42 may be a motor suitable for changing the tilt angle. In a preferred embodiment, the angle actuator 42 is a rotary motor that rotates when activated. In such an embodiment, the shaft 43 extends from the angle actuator 42 into the receiver 45 or into another structure that is not fixed and is movable independently of the angle actuator. The shaft 43 and the corresponding receiver 45 can be in corresponding shapes, such as a tight fit or a complementary key arrangement, so that the rotation of the shaft 43 given by the angle actuator 42 corresponds to the rotation of the mating receiver 45. 【0042】 For example, in the embodiments of Figures 11, 12A, and 12B, the shaft 43 has a keyed configuration such that it has an irregular shape, such as having a flat surface along one side of the rest of its cylindrical shape. The receiver 45 through which the shaft 43 extends is similarly keyed and has a flat surface along at least a portion of its circumference. Thus, when the shaft 43 is rotated by the angle actuator 42, a specific shape engages with a corresponding shape of the receiver 45, transmitting rotational motion to the receiver 45, thereby causing the receiver 45 to rotate as well. Since the receiver 45 is integrated with a component of the positioning device 120 separate from the angle actuator 42, the rotational motion transmitted to the receiver 45 by the interaction of the corresponding shape with the shaft 43 also rotates the rest of the positioning device 120, as shown in Figure 10. The angle actuator 42 may be surrounded by an angle motor housing 44 which may include an opening through which the shaft 43 passes and extends, as seen in Figures 11 and 12A. 【0043】 The positioning device 120 further includes an extender 50, as shown in Figures 7 and 13 to 15B. The extender 50 includes an extender actuator 52 that electrically communicates with a processor 22 and receives extender adjustment data and commands regarding operation and travel distance. Upon receiving the data, the extender actuator 52 is activated to move the through member 10 linearly 51 by a predetermined distance calculated by the processor 22, as shown in Figure 13. In at least one embodiment, the extender actuator 52 is a linear motor, as shown in Figures 13 to 15B, but other forms of motors may be used to achieve movement of the through member along the linear direction 51. 【0044】 The extender 50 also includes an extender shaft 53 extending from the extender actuator 52 to an extender mount 54 located on the opposite side, which is positioned on a separate component of the positioning device 120. The extender shaft 53 can be fixed to the extender actuator 52, the extender mount 54, or both, or formed integrally with them. The extender shaft 53 may retract into or be housed inside the extender actuator 52, or it may share a common housing and be pushed out of the housing by the extender actuator. In some embodiments, as shown in Figure 13, the extender shaft 53 may be a telescopic shaft. In other embodiments, as shown in Figures 15A and 15B, the extender shaft 53 may be a uniform bar or elongated member that moves in and out of the extender actuator 52 when operated. The distance the extender shaft 53 is pushed out from the extender actuator 52 is indicated and calculated by the processor of the processor 22 based on positioning information of a target point 29 entered by the user on the display 24. The extension shaft 53 is made of a rigid material, and as the extension shaft 53 moves, the extension mount 54 to which it terminates moves in correspondence. In this way, the through member 10 is moved by the extension actuator 52 by a distance calculated in the linear direction 51, as shown in Figure 13. 【0045】 In some embodiments, an extension actuator 52 is used to move the penetrating member 10 by a calculated distance, such as moving the penetrating member 10 so that its tip contacts the patient's skin or tissue 5, thereby aligning or positioning it for use. In other embodiments, the extension actuator 52 is used to unfold the penetrating member 10 so that its tip moves from a ready position to the position of a target point 29. In at least one embodiment, an extension actuator 53 is used to align and unfold the penetrating member 10 linearly toward the target point 29. Both the alignment and unfolding of the penetrating member 10 can be automated. In at least one embodiment, the unfolding of the penetrating member 10 occurs as a result of the activation of a button or a specific area of ​​a display 24, such as a soft or virtual button on a touchscreen, or a button on a joystick or other component, which can be operated independently of the alignment and positioning of the penetrating member 10 in various other dimensions by the user's placement of a detector 20 and the operation of vertical and angular actuators 32, 42. 【0046】 The insertion device 100 also includes a vibrator 60, as shown, for example, in Figures 7, 16A, and 16B. The vibrator 60 includes a vibrating actuator 62 that telecommunicates with a processor 22 and receives from the processor 20 vibration data instructing when to activate, the type of vibrating actuator 62 to be used, which is determined by the processor 20 and obtained based on various factors, and operating parameters to be used, including but not limited to the type and state of the tissue 5 to be penetrated. When activated, the vibrating actuator 62 provides the penetrating member 10 with a repetitive reciprocating or vibrating motion back and forth along the longitudinal direction 61. The longitudinal direction 61 coincides with the axis of the penetrating member 10. The terms “reciprocating,” “oscillating,” and “vibrating” as used herein can be used interchangeably and refer to back and forth motion in the longitudinal direction 61 which coincides with or is parallel to the length of the penetrating member 10. 【0047】 The vibration actuator 62 is turned on when it receives a start signal from the processor 22. Activation may occur automatically or only at a point in the insertion process, such as when the through member 10 is properly positioned and aligned but before it is unfolded for insertion. Thus, the operation of the vibration actuator 62 may occur only when the proper positioning of the through member 10 is confirmed by the user in some embodiments, or it may start automatically when the target point 29 is aligned. 【0048】 The vibrator 60 includes a drive shaft 68 extending from the vibration actuator 62 to a coupler or housing connected to the through member 10. The drive shaft 68 transmits the mechanical vibration motion generated by the vibration actuator 62 to the through member 10. The vibrator 60, and therefore the vibration actuator 62, may be axially offset from the through member 10 in some embodiments, as shown in Figures 16A and 16B, or they may be inline or coaxial with the through member 10, as shown in Figures 20A and 20B. 【0049】 In at least one embodiment, as shown in Figures 16A and 16B, the vibration actuator 62 is offset axially from the through member 10. Here, the vibration assembly 60 includes a drive shaft 68 extending from the vibration actuator 62 to a drive coupler 69. In some embodiments, the drive shaft 68 extends at least partially into the drive coupler 69. The drive coupler 69 is adjusted, for example, by connecting to an offset coupler 70. For example, at least a portion of the drive coupler 69 may extend into an offset coupler 70, and vice versa. The offset coupler 70 includes a hub 71 to which the proximal end of the through member 10 is connected by a screw, torsion, threading, keying, or other suitable connection. The drive coupler 69 and the offset coupler 70 extend perpendicularly to the drive shaft 68 and the through member 10. Therefore, the drive coupler 69 and the offset coupler 70 collectively transmit the vibration motion generated by the vibration actuator 62 and propagated by the drive shaft 68 to the through member 10 along different parallel axes. 【0050】 In at least one other embodiment, as shown in Figures 20A and 20B, the vibrator 60' and vibration actuator 62' of the insertion device 100' are coaxial or inline with the through member 10. In such an embodiment, the drive shaft 68' extends from the vibration actuator 62' to a portion of the housing 73. The housing 73 may also include the vibration actuator 62', with its distal end, to which the through member 10 connects, connected to the hub 71. In some embodiments, the housing 73 may further include a neck 74 extending between the housing 73 and the hub 71, for example, when additional space is required. 【0051】 Regardless of whether the vibrators 60, 60' are offset from or inline with the penetrating member 10, the vibration of the penetrating member 10 by the vibrating actuator 62 can be achieved in a variety of ways that can be selected based on the type of tissue being penetrated. Specific operating mechanisms and insertion forces that help overcome tissue deformation will interact beneficially with the resonance and other mechanical properties of the tissue, blood vessels, or other structures encountered by the advancing tip of the penetrating member 10, depending on the resonant frequency and other electromechanical properties of the system. 【0052】 For example, in at least one embodiment, the vibration actuator 62 is a piezoelectric motor. Conventional transducer technologies that rely on single or stacked piezoelectric ceramic assemblies for operation can be hampered by the maximum strain limit of the piezoelectric material itself. The maximum strain limit of conventional piezoelectric ceramics is about 0.1% for polycrystalline piezoelectric materials such as lead zirconate titanate (PZT) and 0.5% for monocrystalline piezoelectric materials, so approaching displacements or operations of several millimeters or tens of microns would require large stacks of cells. Using large stacks of cells to actuate components would also require increasing the size of medical tools beyond the usable biometric designs of handheld devices. 【0053】 A flexational transducer assembly design has been developed that provides amplification of strain displacement in piezoelectric material laminations. The flexational design features piezoelectric material transducer drive cells located within a frame, platen, end cap, or housing. The shape of the frame, platen, end cap, or housing amplifies the axial or longitudinal movement of the driver cells, resulting in greater displacement of the flexational assembly in a particular direction. Essentially, the flexational transducer assembly more efficiently converts strain in one direction into movement (or force) in a second direction. 【0054】 Therefore, as shown in Figure 16B, the vibration actuator 62 is a flexational transducer comprising multiple piezoelectric elements 63 stacked together with electrodes 65 positioned between adjacent piezoelectric elements 63. The multiple piezoelectric elements 63 and electrodes 65 are stacked to form a piezoelectric laminate 64. An insulator 66 covers the ends of the laminate 64, shielding the rest of the device from the energy generated by the piezoelectric elements 63. A rear mass 67, positioned on the opposite side of the insulator 66, applies tension to the piezoelectric laminate 64, keeping the laminate 64 compressed against each other to increase efficiency. At least the piezoelectric laminate 64, preferably the insulator 66 and the rear mass 67 are also cylindrical, with a hollow bore running through the center. The drive shaft 68 extends through this hollow bore through the vibration actuator 62. When the electrode 65 is electrically stimulated, for example when the vibration actuator 62 receives a signal from the processor 22 and operates, the electrical energy transmitted through the electrode 65 is converted into mechanical vibration energy by the piezoelectric element 63, and then transmitted to the drive shaft 68, which moves the drive shaft 68 in a linear direction 61 with repetitive vibration motion. 【0055】 Various flexational transducers can be used as vibration actuators 62, 62'. For example, in one embodiment, the flexational transducer is of the cymbal type, as described in U.S. Patent No. 5,729,077 (Newnham), which is incorporated herein by reference. In another embodiment, the flexational transducer is of the amplified piezoelectric actuator ("APA") type, as described in U.S. Patent No. 6,465,936 (Knowles), which is also incorporated herein by reference. In yet another embodiment, the transducer is a Langevin or bolted dumbbell type transducer, similar to, but not limited to, that disclosed in U.S. Patent Application Publication No. 2007 / 0063618A1 (Bromfield), which is also incorporated herein by reference. Figure 16B shows a specific example of implementing a Langevin transducer as vibration actuator 62. 【0056】 In one embodiment, the flexational transducer assembly can utilize flexational cymbal transducer technology, and in another embodiment, it can utilize amplified piezoelectric actuator (APA) transducer technology. The flexational transducer assembly achieves superior amplification and performance improvements compared to conventional handheld devices. For example, amplification can be improved by up to approximately 50 times. Furthermore, the flexational transducer assembly allows for a simpler and more compact housing configuration. When electrically activated by an external electrical signal source, the vibrating actuators 62, 62' convert the electrical signal into mechanical energy, resulting in vibrating motion of the penetrating member 10. The vibrations generated by the vibrating actuators 62, 62' are short increments (e.g., displacement of up to 1 millimeter) and at frequencies (e.g., approximately 125-175 Hz) that reduce the force required for puncture and sliding through tissue, thereby improving insertion control with less tissue deformation and trauma, ultimately resulting in a higher success rate of vascular penetration / access. 【0057】 The vibrational motion generated by the vibration actuators 62, 62' produces waves that can be sinusoidal, square, standing, sawtooth, or other types of waves in various embodiments. In the case of the Langevin actuator, as shown in Figure 16B, the vibrational motion generated by the piezoelectric element 63 generates standing waves throughout the assembly. At certain frequencies, the standing waves consist of a continuous series of zero-displacement (nodes, or zero nodes) and maximum-displacement (wave antinodes), so that the displacement occurring at any point along the vibration actuator 62 depends on where the displacement is measured. Therefore, the horn of the Langevin transducer is typically designed to be long enough to place the distal end of the horn at a wave antinode when the device is in operation. In this way, the distal end of the horn experiences a large vibrational displacement in the longitudinal direction 61 relative to the long axis of the vibration actuator 62. Conversely, the zero node is the ideal location for adding a port opening or slot to allow connection of external devices. 【0058】 In other embodiments, the vibration actuators 62, 62' may be voice coils for drive actuators instead of piezoelectric elements. Voice coil actuators (also called “voice coil motors”) produce low-frequency reciprocating motion. The bandwidth of the voice coil is approximately 10–60 Hz, and displacements of up to 10 mm depend on the applied AC voltage. In particular, when an alternating current is applied to the conductive coil, a Lorentz force is generated in a direction defined by the cross product between the direction of the current flowing through the conductive coil and the magnetic field vector of the magnetic member. This force results in reciprocating motion of the magnetic member relative to the coil support tube, which is held in place by the main body. The magnetic member, fixed to the drive tube, transmits this motion to an extension member such as a drive shaft 68, which in turn transmits motion to the through member 10. A first mounting point fixes the distal end of the coil support tube to the main body. A second mounting point fixes the proximal end of the coil support tube to the main body. The magnetic member may be made of a neodymium-iron-boron (NdFeB) composition. However, other compositions such as samarium cobalt (SmCo), alnico (AlNiCoCuFe), strontium ferrite (SrFeO), or barium ferrite (BaFeO) may be used, but are not limited to these. In some embodiments, such as when the physical size of the system is relatively small and a strong magnet is too powerful, a slightly weaker magnet may be more optimal. 【0059】 The conductive coil may be made in different configurations, including, but not limited to, several layers formed by a single wire, or several layers formed by wires of different circular or other geometric shapes. In a first embodiment of the conductive coil, the first layer of conductive wire is formed by winding the wire radially around the coil support tube, with each complete turn forming the next turn after the previous turn, and the wire descending along the first longitudinal direction of the coil support tube in a helical manner. After a predetermined number of turns, the first turn of the second layer of wire is superimposed on the last turn of the first layer to form a second spiral of wiring with at least the same number of turns as the first layer, while continuing to wind the wire in the same radial direction as the first layer, and an additional layer is formed on the first layer, with each turn formed next to the previous turn and in the longitudinal direction opposite to the direction in which the first layer was formed. Additional layers can be added by overlapping the first turn of each additional layer of wire with the last turn of the previous layer, continuing to wind the wire in the same radial direction as the previous layer, and forming an additional spiral of wiring with at least the same number of turns as the previous layer, each turn being formed next to the previous turn in the longitudinal direction opposite to the direction in which the previous layer was formed. In another embodiment of the voice coil, the positions of the magnetic member and the conductive coil are reversed. In other words, the conductive coil is wound around and mounted on the drive tube, and the magnetic member is positioned along the outer diameter of the coil support tube. An electrical signal is applied to the conductive mounting area, and a Lorentz force is formed in alternating directions that move the conductive coil and the stretching member toward each other along the longitudinal axis of the device. In this embodiment, the conductive coil is in physical contact with the drive tube. 【0060】 In another embodiment, the vibration actuators 62, 62' use a double-coil mechanism in which the magnetic member of the voice coil is replaced by a second conductive coil. In other words, the second conductive coil is wound around and mounted on the drive tube, and the first conductive coil is positioned along the outer diameter of the coil support tube as before. In the first version, the inner coil conducts direct current (DC) and the outer coil conducts alternating current (AC). In the second version, the inner coil conducts alternating current (AC) and the outer coil conducts direct current (DC). In the third version, both the inner and outer coils conduct alternating current (AC). In all of the voice coil actuator configurations described, springs can be used to limit and control specific dynamic aspects of the through member 10. 【0061】 In yet another embodiment, the vibration actuators 62, 62' are solenoid actuators. Similar to other voice coil embodiments using coils, the basic principle of operation by the solenoid actuator is caused by a time-varying magnetic field generated within a solenoid coil acting on a pair of very powerful permanent magnets. The entire assembly of magnets and through member vibrates back and forth through the solenoid coil. The spring absorbs and releases energy in each cycle, amplifying the vibrations observed in the through member 10. The resonance characteristics of the vibration actuators 62, 62' can be optimized by the selection of magnets, the number of turns in the solenoid coil, the mass of the shaft, and the stiffness of the spring. 【0062】 While piezoelectric and voice coil mechanisms have been discussed for the vibration actuators 62, 62', these are not the only approaches for acting on or vibrating the through member 10. Other approaches, such as rotary motors, can be used for the vibration actuators 62, 62'. In general, any type of motor including an actuator assembly further comprising a mass coupled to a piezoelectric material, a voice coil motor, a solenoid, or any other translational motion device also falls within the spirit and scope of the present invention. 【0063】 During use, feedback to track or confirm that the vibrating tip of the penetrating member 10 has reached the desired target point 29 can be obtained in several forms. Firstly, the vibrating tip of the penetrating member 10 can be visualized on the display 24, as its echo is picked up by the detector 20 during imaging in progress by the insertion process. This can be done while viewing the image in a longitudinal or transverse view (as in Figure 5C), or the user can follow the progress of the tip of the penetrating member 10 by switching between longitudinal and transverse views as needed. Secondly, the appearance of fluids such as blood in the penetrating member, also known as a "flashback," can be detected by mechanisms such as visual identification, changes in resistance to subcircuits, or changes in the resonant frequency or phase of the vibrating needle tip. Other methods can also be used to confirm that the tip of the penetrating member 10 has reached a pre-selected target point 29. 【0064】 After the tip of the penetrating member 10 is successfully inserted into the target vessel and positioned at the desired target point 29, the remainder of the procedure for successful central venous catheterization discussed above can be achieved according to the Seldinger method. For example, in one embodiment, a guidewire 83 can be supplied through the penetrating member 10 for insertion into the target vessel. Thus, the penetrating member 10 may be sized to accommodate a guidewire 83 having an inner diameter at least the same size as the diameter of the guidewire 83 to be inserted therein. For example, in some embodiments, the penetrating member 10 is between 14 and 18 gauge, and the outer diameter of the guidewire 75 may be in the range of 0.9 to 0.6 millimeters (0.035 to 0.024 inches). Of course, other sizes and gauges are also intended herein. The guidewire 83 can extend 1 to 3 cm beyond the tip of the penetrating member 10, but shorter and longer distances for guidewire insertion are also intended. For example, the guide wire 83 may be supplied through an internal volume or space 72 of an offset coupler 70 having an opening that aligns with the hub 71 and thus the through member 10, as seen in Figure 16B. In other embodiments, as shown in Figures 21A to 22, the guide wire 83 may be supplied through a lumen 76 of a side port 75 of the housing 73 of the vibrator 60', such as a neck 74 in front of the hub 71. The housing 73, neck 74, side port 75, and hub 71 may all be formed integrally together, or they may all be separate components that can be selectively attached to each other using a Luer connection or other suitable selectively detachable connection mechanism or any combination thereof. For example, in some embodiments, the side port 75 is formed integrally with a neck 74 that can be attached to the housing 73 at one end and to the hub 71 at the other end, as shown in Figure 21B. Thus, the neck 74 and side port 75 may be a Y-adapter. In other embodiments, the side port 75 may be attached separately from the housing 73 or neck 74. In yet another embodiment, the neck 74, side port 75, and hub 71 can be integrally formed and connected to the housing 73. 【0065】 Once the guidewire 83 is inserted through the penetrating member 10 and positioned within the target vessel as needed, the penetrating member 10 can then be retracted from the vessel by an extension actuator 52 that moves in the opposite direction along the linear direction 51, leaving the guidewire 83 in place. The space can also be expanded by inserting or withdrawing a dilator as needed. The catheter can then be inserted onto the guidewire, the guidewire can be withdrawn from the vessel, and the catheter can be left in place. 【0066】 The vertical actuator 32, angle actuator 42, extension actuator 52, and vibration actuator 62 are incorporated into the insertion device 100. Thus, in at least one embodiment, the penetration member 10 can be selectively removed from the insertion device 100, such as by attachment and detachment at the hub 71, so that a sterile penetration member 10 can be used for a new patient or for each use. Thus, the penetration member 10 can be disposable, and the rest of the insertion device 100, including the detector 20, processor 22, and various actuators 32, 42, 52, 62, remains intact and reusable. 【0067】 In at least one embodiment, at least a portion, preferably the entirety, of the insertion device 100 including the hub 71, up to the hub 71, is reusable and can be contained in a sterile bag to maintain sterility. In some embodiments, the sterile bag can be wiped with alcohol or bleach, etc., between patient use, so that complete sterility measures are not required for the reusable insertion device 100 between each use. In other embodiments, the hub 71 may be detachable from the offset coupler 70 or housing 73 for sterilization between use or disposal. In yet another embodiment, the offset coupler 70 or housing 70 may be detachable from the rest of the device 100, 100'' for sterilization between use or disposal. Throughout the various embodiments, the reusable portion of the insertion device 100, 100'' is intended to be contained in a sterile bag or similar structure to maintain sterility between use. 【0068】 In at least one embodiment, as shown in Figures 17–19B, the insertion device 100' may include a guidewire adjuster 80 for inserting the guidewire 83 as instructed by the processor 22. The guidewire actuator 82 communicates with the processor 22 and receives operation data from the processor 22, instructing it on operation and operating parameters based on the type of actuator, the position of the guidewire, etc. For example, in at least one embodiment shown in Figures 18A and 18B, the guidewire actuator 82 is a rotary motor which may have at least one, possibly two, elongated members 85 extending from the guidewire actuator 82. A gear 84 of the guidewire actuator 82 rotates at least one of the elongated members 85. In some embodiments, only one elongated member 85 is active and is primarily engaged by the gear 84 for turning or rotating. Another elongated member 85 may also be present and paired with the first active elongated member, but may be passive so as not to be rotated by the guidewire actuator 82. Therefore, the passive elongated member 85 can only be rotated by an action corresponding to the movement of the paired active elongated member 85, for example, by the mutual engagement of the teeth on the adjustment gear 84 between the elongated members 85. 【0069】 On the opposite side of the guidewire actuator 82, the elongated member 85 includes a friction member 86. In at least one embodiment, each elongated member 85 includes a friction member 86 which may be at the end of the elongated member 85. In other embodiments, only the primary elongated member 85 includes a friction member 86, but preferably both the active and passive elongated members 85 include their respective friction members 86. In embodiments with multiple active elongated members 85, each includes a friction member 86. The friction member 86 grips the guidewire 83 and uses friction engagement to move the guidewire 83 as the guidewire 83 rotates. In some embodiments, as shown in Figures 18A and 18B, the guidewire 83 is mounted and sealed in a guidewire housing 89 so that the guidewire 83 can be kept sterile when not in use. In some embodiments, the guidewire 83 is held as a spool 88 within the housing 89 for compact storage and can be easily rewound as needed. In other embodiments, the guide wire 83 may extend from the insertion device 100' and may be supplied through the device 100' as needed. Whether wound on a spool or not, as the guide wire actuator 82 rotates the elongated member 85, the friction member 86 engages with the guide wire 83 and rotates to move the guide wire 83, advancing or retracting the guide wire depending on the direction of rotation. 【0070】 The guide wire 83 moves through the guide wire channel 87 within the guide wire housing 89. The guide wire channel 87 is aligned with and fluidly communicates with the interior 72 of the offset coupler 70, so that the guide wire 83 advances through the channel 87, through the interior 72 of the offset coupler 70, the hub 71, and the through member 10. The guide wire 83 can advance beyond the tip of the through member 10, as described above. The guide wire 83 can be retracted via the same route and mechanism as the insertion device 100', but with the elongated member 85 and friction member 86 rotating in opposite directions. 【0071】 The guide wire 83 also needs to be sterilized before use. Therefore, in some embodiments, such as those shown in Figures 19A and 19B, everything that the guide wire 83 comes into contact with can be selectively removable and disposable for single use, etc. For example, the guide wire housing 89, including the spool 88, along with the guide wire channel 87, offset coupler 70, hub 71, and through member 10, can all be separated from the rest of the insertion device 100' so that the detector 20, processor 22, and actuators 32, 42, 52, 62, and 82 can all be kept sterilized and reusable. This is one advantage of having the offset alignment of the through member 10 from the vibrating actuator 62. In other embodiments, only the guide wire 83 and through member 10 can be removed and disposable, and the guide wire channel 87, offset coupler 70, and hub 71 can be sterilized after each use. 【0072】 In yet another embodiment, as shown in Figure 20C, the guidewire 83 passes through the vibrating actuator 62. In such an embodiment, the vibrating actuator 62 and the drive shaft 68 may have aligned lumens extending through them, which function as guidewire channels 87. The guidewire 83 can move forward and backward through these lumens. Additional Embodiments Figures 23 to 28 show further embodiments of the automatic insertion device 300 and the method of using it 400. These embodiments are handheld devices that can be used to automatically insert a penetrating member 310, such as a needle or catheter, into a body cavity such as a blood vessel, for access to blood and fluids, as well as for the placement of catheters such as guidewires, dilators, and CVCs. 【0073】 As shown in Figure 23, the insertion device 300 includes a detector 326 for visualizing a subcutaneous target site. As in previous embodiments, the detector 326 may be an ultrasound probe capable of generating an image of the target site using ultrasound, but other types of image detectors are also conceivable. The detector 326 communicates with a control unit 319 and provides the control unit 319 with image data acquired by the detector 326. This imaging data may be relayed to a display for viewing by a physician or a user of the device 300. An arm 325 connects the detector 326 to the rest of the device 300. A handle 321, which can be grasped by an operator during use, is attached to the arm 325 so that the device 300 can be operated to align the detector 326 until the appropriate target site is identified. The terms “physician,” “operator,” “user,” and other similar terms used herein may be used interchangeably to refer to a person who uses the device to control the insertion of a penetrating member. 【0074】 The control unit 319 further includes a processor 322 that can receive imaging data from the detector 326 and further process the imaging data, such as by converting the automatically calculated imaging data 323a into target information corresponding to the coordinates of a specified target site in three-dimensional space, including an X and Y coordinate solution representing the depth index of the target site determined from the image data, as shown in Figures 26 and 27. The processor 322 may be a microprocessor or one of the above. The control unit 319 also includes a memory 219, shown in Figure 26, which may store imaging data from the detector 326 and target information. The processor 322 further includes a function to calculate the insertion angle of the penetrating member 310 entering the tissue based on depth and other three-dimensional target information. In some embodiments, the processor 322 includes a manual adjustment 323b option, which allows the user to manually adjust the angle of the positioning device 320 to optimize the entry angle of the penetrating member 310. 【0075】 The detector 326 remains adjacent to the skin surface during use of the device 300. The corresponding imaging data, including depth telemetry and X and Y target coordinates of the target site provided by the detector 326, may change during the insertion process based on deformation or movement of the underlying tissue. Thus, the imaging data is repeatedly collected by the detector 326 at regular intervals, such as every 20 milliseconds in at least one embodiment. Each iterative image data is provided to the processor 322, which uses automatic calculation 323a to recalculate and update the target information for each iterative packet of received image data to ensure that the penetration member 310 proceeds to the selected and stored target and remains on course. 【0076】 As shown in Figure 24, the apparatus 300 may include a positioning device 320 on which a control unit 319 can be mounted. The positioning device 320 may also include a vibrating assembly 360 and a stretching assembly 350 in a manner that supports, accommodates, and otherwise holds the vibrating assembly 360 and the stretching assembly 350, as will be discussed in more detail below. A penetrating member 310 is attached to the distal end of the vibrating assembly 360 and is moved along an insertion axis 311 defined by target information for insertion into tissue by movement of the stretching assembly 350. The positioning device 320 may be a platform or housing that surrounds the components. In some embodiments, the processor 322 may further provide commands to the positioning device 320 on which the vibrating assembly 360 and the stretching assembly 350 are located, for example by rotation, to adjust the angle of the penetrating member 310 according to the target information described above. 【0077】 The positioning device 320 may also include at least one surface proximity sensor 325, schematically shown in Figure 27, preferably located on the outer and / or distal surface of the positioning device 320, to detect contact between the positioning device 320 and the tissue surface. Such detection may indicate that the penetrating member 310 is not long enough to reach the selected target site and another penetrating member 310 may be required, or that the target information calculated based on the image data needs to be updated and the insertion angle changed to avoid contact between the positioning device 320 and the tissue surface. Thus, the processor 322 may receive contact information from the surface proximity sensor 325 indicating that contact between the positioning device 320 and the tissue surface has occurred. If such contact information is received, the processor 322 can recalculate the target information to avoid further contact. If there is no contact information from the surface proximity sensor 325, the processor 322 can verify the appropriateness of the target information, whether it is the initial target information or one updated based on repeated imaging data. 【0078】 The control unit 319, specifically the processor 322, communicates electronically with the vibration assembly 360 and the extension assembly 350, which will be described in more detail below, and can provide commands by transmitting target information and operation commands based on updated target information to the vibration assembly 360 and the extension assembly 350. 【0079】 The apparatus 300 includes a vibration assembly 360, shown in Figures 23 and 24, configured to generate vibrations in the longitudinal direction 61, as described above for previous embodiments. It is connected to the through member 310, either directly or via a hub 371 as shown in Figure 24, so that the vibration or oscillation generated by the vibration assembly 360 is transmitted to the through member 310. The vibration assembly 360 includes a vibration actuator 362, such as a motor, which generates vibration or oscillation when in operation. The terms “vibration” and “oscillation” as used herein are interchangeable. The vibration actuator 362 may be any suitable motor, such as, but not limited to, a voice coil motor (VCM), a piezoelectric motor having at least one piezoelectric element, and a DC motor. Depending on the type of vibration actuator, frequency, and / or input power, the vibration actuator 362 may generate vibrations at a rate of 50 to 50,000 vibrations per second. In at least one embodiment, the vibration velocity may preferably be up to about 150 vibrations per second. The generated vibrations can cause the through member 310 to vibrate with an amplitude of about 5 μm to 1 mm, preferably 0.5 mm in at least one embodiment. 【0080】 The vibration actuator 362 communicates with the control unit 319, specifically the processor 322, and receives operation commands from the control unit 319. For example, the device 300 may include a vibration power switch 368, shown in Figure 25, which may be an on / off switch that communicates with the control unit 319. When activated or switched on, the control unit 319 sends a signal to the vibration actuator 362 to turn it on and begin generating vibrations specified by the control unit 319. Turning off the vibration power switch 368 stops the vibrations. In other embodiments, it may also communicate directly with the vibration actuator 362 and, in some embodiments, may be a potentiometer or have the ability to adjust the power supplied to the vibration actuator 362 along a continuum rather than being on or off. 【0081】 Referring to Figure 27, which shows the electrical flow diagram of the device 300, the vibration assembly 360 includes a vibration control 372, which is an electrical module that determines the relative output level at which the vibration actuator 362 should operate in response to signals received from the control unit 319, the processor 322, vibration control mode 322c (an optional sub-component of the processor 322), and / or the extension assembly 350 described below. The output level of the vibration actuator 362 is governed by the voltage and / or drive signal frequency applied to the actuator. Instructions are sent from the control unit 319, the processor 322, or vibration control mode 322c to the vibration control 372, which relays the operation instructions to the vibration driver 367, which then transmits signals such as voltage to the vibration actuator 367 to start and / or continue the operation of the vibration actuator 367. The vibration actuator 362 may include sensors to detect the amplitude, power consumption, and load experienced by the penetration member 310 during insertion. This information is relayed to the stretch assembly 350 directly or indirectly via the control unit 319 or processor 322, as will be described in more detail below. 【0082】 A vibration load sensor 374 may be included to detect the load on the penetrating member 310 and to detect the damping of vibrations experienced by the penetrating member 310 during insertion. The vibration actuator 362 operates at a certain frequency, but this frequency shifts when the coupled vibrating penetrating member 310 engages with tissue. This is because the additional elasticity of the biological tissue increases the stiffness of the combined system (vibrating actuator 362 and tissue). When the vibrating penetrating member 310 engages with tissue, the tissue weakens the amplitude and effectiveness of the vibration. To limit the damping of the amplitude and effect of the vibration, the frequency / voltage of the drive signal to the vibration actuator 362 must be changed. Changing the frequency / voltage of the drive signal requires supplying additional power to the vibration actuator 362 to limit the damping of the amplitude. The amount of energy (such as watts) supplied to the vibration actuator 362 is called vibration power consumption. Vibration power consumption can also be detected via a voltage sensing element within the vibration assembly 360 according to the following formula. Power = Irms * Vrms Here, Irms is the current and Vrms is the voltage. The vibration power consumption can be determined from the current and voltage measured by the vibration actuator 362. Therefore, damping the vibration amplitude requires additional power consumption to counteract the damping. 【0083】 The "load" is the axial force applied to the through member 310 m Newtons (N), and can be detected by the vibration load sensor 374 that measures the force. The vibration assembly 360 is configured to transmit a signal indicating the vibration load to one of the control unit 319 and the extension assembly 350.The vibration load sensor 374 may be a circuit or other suitable mechanism. In one embodiment, the vibration load sensor 374 may be a shunt resistor and an amplifier. In other embodiments, the load and damping of the through member 310 can be mechanically sensed using an LVDT sensor. The vibration actuator 362 itself may also function as a vibration load sensor, receiving feedback of forces applied to the through member 310 via a coil or magnet within the vibration actuator 362, and may receive such forces as well. Furthermore, the power consumed by the extension actuator when the through needle encounters harder tissue can also be adjusted based on the “load” as defined herein. Alternatively, the phase relationship between the load current and voltage of the vibration actuator 362 can be monitored, and the effect of damping or load on the through member 310 can be inferred from changes in this phase relationship. 【0084】 The damping of the through member 310 and the load current of the vibration actuator 362 are related to the operating parameters of the vibration actuator 362 and may be sent to the vibration power and load control 376 module, which determines the load and damping effect experienced by the through member 310. The vibration load control 376 can send signals to the vibration motor control 372, processor 322, and / or vibration mode control 322c to adjust the vibration speed based on the feedback from the through member 310. Alternatively, this information can be sent directly to the extension assembly 350 or via the control unit 319 and / or processor 322 to adjust the insertion speed based on the vibration load experienced by the through member 310 under vibration. 【0085】 The apparatus 300 also includes an extension assembly 350, as shown through the figures. As described above, the extension assembly 350 is configured to move the through member 310 in a linear direction 51 for insertion and retraction of the through member 310. The extension assembly 350 includes an extension actuator 352, which is a motor such as, but not limited to, a linear or translational motor, and can be operated by any suitable mechanism. The extension shaft 353 is mechanically coupled to the extension actuator 352 at one position via an extension mount 354, etc., as shown in Figure 24, and at another spaced position is mechanically coupled to the through member 310, the hub 371, the vibration actuator 362, or any other component that can move with the through member 310. The extension shaft 353 is preferably rigid and can be extended by extension or retraction in at least one embodiment. The extension assembly 350 communicates electronically with the control unit 319 and / or the processor 322 to provide and receive operation commands. For example, the extension assembly 350 may also include an extender power switch 357, which can be mounted anywhere on the device 300, such as on the control unit 319, the outer surface of the positioning device 320, or the handle 321, as shown in Figure 25. The extender power switch 357 can be used to turn the extension assembly 350 on or off. In at least one embodiment, the extender power switch 357 closes the circuit, providing operating power to the extension actuator 352, which moves the extension shaft 353 in a linear direction 351. The direction of movement can be controlled by a direction switch 356, shown in Figure 25, which can also be located anywhere on the device 300. The direction switch 356 may be a switch that can toggle between a forward direction for advancing the extension shaft 353 for insertion of the through member 310 and a reverse direction for retracting the extension shaft 353 and removing the through member 310. The ready or retracted position of the extension assembly 350 is shown in Figure 23 with the extension shaft 353 fully retracted, and the inserted or deployed position is shown in Figure 24 with the extension shaft 353 fully extended in the linear direction 51. 【0086】 The extension actuator 352 is configured to operate at various speeds to insert the through member 310 at different speeds, depending on the vibration load and / or damping experienced by the through member 310 during insertion. For example, in at least one embodiment, the extension actuator 352 operates at a first operating speed in a first mode, at a second operating speed in a second mode, and at a third operating speed in a third mode. Any number of modes are possible, each with its own operating speed. The operating speed may be a range or a specific speed, or any speed along a continuum of possible speeds based on the capabilities of the particular extension actuator 352 used. For example, in at least one embodiment, the extension actuator 352 is configured to operate at a first operating speed of about 2.0 cm / sec in the first mode, about 1.0 cm / sec in the second mode, and 0.5 cm / sec in the third mode. Thus, various modes can be used to adjust the insertion speed depending on what the through member 310 encounters during insertion. For example, if the load or vibration damping experienced by the through member 310 increases, a slower insertion speed can be used, and if the load or vibration damping experienced by the through member 310 is small, a faster insertion speed can be used. Unless otherwise determined, one of the operating modes can be set as the default mode in which the extension actuator 352 operates, as described below. For example, in at least one embodiment, the extension actuator 352 can use a first mode with an operating speed of 2.0 cm / second, which reduces the insertion speed to compensate for the increased vibration load experienced during insertion. 【0087】 Power consumption can also be defined by the power required by the extension motor to continue moving forward as different tissues are penetrated by the attached penetration member 310. This power consumption is sometimes called extension power consumption. The extension actuator 352 itself may also be a sensor of how much resistance is encountered in the penetration member 310 during insertion, such as when encountering denser tissue, which may increase the extension power consumption of the extension actuator 352 to continue operating at a particular insertion speed. The stretching assembly 350 is configured to transmit a signal indicating the insertion load to one of the control unit 319 and the vibration assembly 360. Therefore, feedback on the stretch power consumption and current insertion speed can be transmitted directly or indirectly to the vibration assembly 360 via the control unit 319 and / or processor 322 to adjust the vibration based on the stretch power load experienced by the through member 310 as the stretch actuator 352 experiences during insertion. 【0088】 The extension assembly 350 also includes electrical circuits for sending and receiving signals and information to the control unit 319, processor 322, and vibration assembly 360. For example, as shown in Figure 27, the extension assembly 350 may include an extension motor control 358 that receives operating signals from the control unit 319, such as to activate the extension actuator 352 when the extension power switch 357 is activated, or to instruct which operating mode and speed to use. The defined parameters for each operating mode and the corresponding speeds can be stored in memory 318 in the control unit 319 or in memory in the extension motor control 358 or the extension assembly 350. The extension motor control 358 sends operating commands to the extension driver 355, which then sends signals such as voltage to the extension actuator 352 to actuate the extension actuator 352 and move the through member 310 in the direction indicated by the direction switch 356. 【0089】 The extension motor control 358 may also receive signals from the vibration assembly 360, such as from the vibration load control 376, regarding the load and damping experienced by the through member 310. This may take the form of changes in vibration amplitude and / or motor power consumption experienced by the vibration actuator 362 coupled to the through member 310. Preferably, these signals and / or adjustments occur at regular intervals throughout the insertion process, for example, every 20 milliseconds, although other time intervals shorter than the total insertion time are intended. 【0090】 The speed of the stretch actuator 352 can be adjusted by the stretch motor control 358 to increase or decrease in response to changes in the vibration amplitude damping and / or power consumption of the vibration actuator 362 resulting from the load on the penetrating member 310 as the penetrating member 310 progresses through different tissue types. For example, when the penetrating member 310 encounters a stiffer, harder, or more difficult-to-penetrate tissue, such as a tendon, a larger drive signal (e.g., voltage amplitude) is required to dampen the vibration applied to the penetrating member 310, increase the load on the penetrating member 310, change the power consumption of the vibration actuator 362, and / or maintain the vibration displacement. When such an increased load signal is sent to the stretch assembly 350, the stretch actuator 352 responds to the increased load by slowing down the insertion speed. For example, depending on which mode the stretch actuator 352 is currently operating in, it can be adjusted from the first mode to the second mode if the speed is slower, or from the second mode to the third mode if the speed is even slower. Conversely, if the load experienced by the penetrating member 310 decreases, such as when it encounters soft tissue, a signal of the reduced vibration load is sent to the stretcher 352, and the stretch actuator 352 adjusts to a faster operating speed, such as moving from the third mode to the second mode or from the second mode to the first mode for a faster speed. When a change that reaches a predetermined threshold is reached, the operating mode of the stretch actuator 352 changes to the next closest mode, depending on whether the change reflects an increase or decrease in load. 【0091】 The present invention also includes a method 400 using the apparatus 300 described above, as shown in Figure 28. Method 400 first includes the step of determining a target angle and trajectory in 410. This can be achieved by placing the detector 326 on another surface of skin or tissue and using the automatic calculation 323a of the processor 322 to determine an appropriate insertion angle and distance from the current position of the penetrating member 310 to the selected target. In certain embodiments, this may include the step of determining the target angle based on the manual adjustment 323b described above. The selected target site, determined or calculated insertion angle and distance can be stored in the memory 318 of the control unit 319. 【0092】 Method 400 continues, as in 415, by providing operational commands for vibration parameters to the vibration assembly 360 and for insertion speed and distance to the stretch assembly 350. For the vibration assembly 360, these may include amplitude, voltage, vibration frequency, and other parameters as described above. For the stretch assembly 350, the operational parameter for insertion speed may be the speed corresponding to the default mode. The distance corresponds to target information and trajectory determined based on imaging information from the detector 326, as may be determined by the control unit 319 and / or the processor 322. The operational commands may be provided to each assembly 350, 360 when the device 300 is turned on, or they may be stored in the circuitry or memory of the vibration assembly 360 or in the memory of the control unit 319. 【0093】 Method 400 follows, as in 420, initiating the positioning device 320. This may include turning on the positioning device 320, the vibration actuator 362, and the extension actuator 352. This may occur stepwise, one at a time, or simultaneously. In at least one embodiment, the vibration actuator 362 is actuated before the extension actuator 352 so that the through member 310 vibrates longitudinally before advancing for insertion. Once activated, actuators 362 and 352 can be contained in their respective circuits, such as the vibration control 372 and the extension motor control 358, and operate according to initial or default operating parameters, which may be contained operational instructions provided by the control unit 319 and / or processor 322 of the device 300. In at least one embodiment, the extension actuator 352 may begin operating in a first mode, and the vibration actuator 362 may operate in a first vibration mode. 【0094】 Method 400 includes the step of monitoring the vibration power consumption and / or vibration displacement provided by the vibration actuator 362, as well as the extension power consumption and / or load of the extension actuator 352, such as detecting the respective workloads continuously or iteratively throughout the insertion process, as in 430. Each iteration of monitoring can be performed at any time interval, such as 20 milliseconds, depending on the desired sensitivity of the system, but is not limited to this. This can be achieved by the vibration load sensor 374 and the extension actuator 352 or other insertion load sensors as described above. Method 440 then includes the steps of comparing the detected vibration load to a predetermined vibration value and comparing the detected insertion load to a predetermined extension value, and if a sufficient deviation of the vibration actuator 362 from the vibration workload is detected, and thereafter, the step of adjusting the insertion speed of the extension actuator 352, and / or if a sufficient deviation of the extension actuator 350 from the extension workload is detected, and thereafter, the step of adjusting the vibration of the vibration actuator 362. These adjustments can be made by providing signals to the appropriate vibration assembly 360 and / or stretch assembly 350 to perform corresponding adjustments, which may depend on the detected change in workload and whether it exceeds a predetermined value in the positive or negative direction. For example, method 400 may include reducing the insertion speed when the vibration load of the vibration actuator 362 increases by a predetermined vibration threshold, as in 442. For example, a predetermined vibration value could be a 30% increase in amplitude and / or a 50% increase in power consumption compared to the initial starting value or the load sample from the most recent iteration sampling. Similarly, method 400 may include reducing the vibration power, amplitude, or other operating parameters when the insertion load of the stretch actuator 352 increases by a predetermined stretch value, as in 443. In some embodiments, a predetermined stretch value could be an increase of 0.25, 0.5, 1.0, 1.5, or 2.0 times the power compared to the initial starting power or the insertion load sample from the most recent iteration sampling.The predetermined vibration and extension values ​​may differ in other embodiments and may depend on many factors, including, but not limited to, the initial starting load and speed, the tissue being penetrated, the characteristics and types of the vibration actuator 362 and extension actuator 352 used, the amount of initial power supplied, and other factors. This reduction in insertion speed may correspond to a transition from one operating mode to the next available operating mode, for example, from a first mode to a second mode, or from a second mode to a third mode, where the level of insertion speed decreases, in order to adjust the insertion speed. It may also correspond to a transition of the vibration actuator 362 from one vibration mode to another. Method 400 intends to change the operating parameters of both the vibration actuator 362 and the extension actuator 352, one or both, depending on the load on the actuator on the opposite side. 【0095】 Conversely, method 400 includes, as in 444, a step of increasing the insertion speed when the vibration load of the vibration actuator 362 decreases by a predetermined vibration value, or, as in 445, a step of increasing the vibration of the vibration actuator 362 when the insertion load to the extension actuator 352 decreases by a predetermined extension value. The predetermined vibration value or extension value for increasing the insertion speed or vibration may be the same as the value for decreasing the insertion speed or vibration, respectively. Thus, the change can also be described as a deviation from a predetermined value, such as a 30% deviation in amplitude and / or 50% deviation in power consumption compared to a previous vibration load sample of the vibration actuator 362, or a 0.5x deviation in insertion load compared to a previous insertion load of the extension actuator 352. However, in other embodiments, the predetermined vibration value and extension value for increasing the insertion speed or vibration may be different from the value for decreasing the insertion speed or vibration. Here again, an increase in insertion speed or vibration may result from a transition to the next available operating mode, such as an increase in insertion speed, a shift from the third mode to the second mode of the extension actuator 352, or a shift from the second mode to the third mode. Furthermore, the sampling rate or interval may remain the same as before, such as every 20 milliseconds, or the sampling rate may change over time. For example, the sampling interval may shorten, the vibration load may increase, the feedback frequency may increase, then lengthen, the vibration load may decrease, the feedback frequency may decrease, or vice versa. In at least one embodiment, the sampling rate or sampling interval may remain constant throughout the entire insertion process. 【0096】 The step of monitoring the vibration load, as in 430, is continued throughout the insertion process, and preferably, between the operating modes of the extension actuator 352 and the vibration actuator 362, adjustments are made to gradually increase or decrease the insertion speed or vibration throughout the insertion process, as needed, based on the load experienced by the other actuator. 【0097】 Method 400 terminates by stopping the insertion, as in 450. This can occur automatically in several ways, for example, when a pre-selected target is reached according to a trajectory calculated or determined based on imaging information. Reaching the target site can be confirmed by the presence of an appropriate amount of blood or fluid escaping from the target, indicating that the distal tip of the penetrating member 310 is located within the internal volume of the blood vessel. Stopping the insertion, as in 450, can also occur if contact between the device 300 and the tissue surface is detected by the surface proximity sensor 325 described above, for example. In this case, the vibration actuator 362 can simultaneously stop vibrating, and the extension actuator 352 can reverse to retract the penetrating member 310. The positioning device 320 can also inform the operator that the length of the penetrating member 310 is insufficient for the intended target depth, by means of light, sound, or other indicators that the operator can observe. 【0098】 When the insertion of the penetration member 310 stops, the active operation of the vibrating actuator 362 and the extension actuator 352 is interrupted by the processor 322. Once the successful introduction of the penetration member 310 into the intended target is confirmed, for example, by the appearance of blood or other bodily fluids suitable for the penetrated tissue, the interior of the target site can become an access point for extracting or inserting material through the penetration member 310. For example, blood can be collected, drugs or solutions can be applied, and / or a flexible guidewire can be inserted through the hollow interior of the penetration member 310. The penetration member 310, which is still present in the target site, may be detached from the device, for example, by removing it from the vibrating assembly 360 at the hub 371, as in 460. The hub 371 can then be used as a connection point for a syringe or vial for blood collection or drug / solution delivery, or as a connection point for an IV system. A guidewire can be inserted through the penetration member 310 before or after detachment from the rest of the insertion device 300. If the guidewire is inserted through the through member 310 while still connected to the device 300, the positioning device 320 and the rest of the device 300 to which the through member 310 is attached may be gently withdrawn from the tissue via the flexible guidewire until the operator can recognize evidence of the flexible guidewire extending from the skin surface, allowing the operator to safely detach the positioning device 320 and the through member 310 from interaction with the flexible guidewire. 【0099】 Since many modifications, changes, and alterations can be made in detail to the preferred embodiments described, all matters shown in the foregoing description and accompanying drawings are intended to be interpreted as illustrative rather than restrictive. Accordingly, the scope of the invention should be determined by the appended claims and their legal equivalents. The invention has now been described.

Claims

[Claim 1] In a device for inserting a penetrating member into tissue along the insertion axis, A control unit having a processor and memory, A detector for acquiring data representing the location of a target site within the aforementioned tissue, the detector communicating electrically with the control unit, A vibration assembly connected to the through member, the vibration assembly having a vibration actuator that electrically communicates with at least one of the control unit and the stretch assembly, the vibration actuator being configured to generate axial vibration along the insertion axis toward the target site in the tissue in accordance with a defined motion vibration command in at least partially response to the insertion load, to transmit the axial vibration to the through member, to detect the vibration load on the vibration actuator, and to transmit a signal indicating the vibration load to one of the control unit and the stretch assembly, The stretching assembly is connected to the through member and electrically communicates with at least one of the control unit and the vibration assembly, and the stretching assembly has a stretching actuator configured to move the through member axially along the insertion axis toward the target site in the tissue at an insertion speed in accordance with a defined motion insertion command in response at least partially to the vibration load, and the stretching assembly is further configured to detect the insertion load on the stretching actuator and transmit a signal indicating the insertion load to one of the control unit and the vibration assembly, The control unit is configured to (a) receive the signals indicating the vibration load and the insertion load, (b) compare the signals indicating the vibration load with a predetermined vibration value, and when the signals indicating the vibration load deviate from the predetermined vibration value, provide an operation insertion command to the extension actuator to change the insertion speed, and (c) compare the signals indicating the insertion load with a predetermined insertion value, and when the signals indicating the insertion load deviate from the predetermined insertion value, provide an operation vibration command to the vibration actuator to change the vibration. [Claim 2] The apparatus according to claim 1, wherein the vibration load is at least one of the amplitude and power consumption of the vibration actuator, and the insertion load is the power consumption of the extension actuator. [Claim 3] The apparatus according to claim 1, wherein the through member is selectively removable from the apparatus. [Claim 4] The apparatus according to claim 1, wherein the extension assembly includes an extension shaft movable relative to the apparatus by the extension actuator, and the extension shaft is connected to the vibration assembly. [Claim 5] The apparatus according to claim 1, wherein the vibration actuator is one of a voice coil motor, a piezoelectric motor, and a DC motor. [Claim 6] The apparatus according to claim 1, wherein the vibration assembly includes a vibration load sensor configured to electrically communicate with the vibration actuator and to detect at least one of the electrical and mechanical indications of the vibration load on the vibration actuator, the vibration load sensor being one of (a) a shunt resistor and amplifier, (b) an LVDT sensor, and (c) the vibration actuator. [Claim 7] The apparatus according to claim 6, wherein the vibration assembly includes a vibration load control configured to electrically communicate with the vibration actuator and to perform at least one of the following: (a) determining the vibration load from at least one of the electrical and mechanical indications from the vibration load sensor, and (b) transmitting the signal indicating the vibration load to one of the control unit and the stretch assembly. [Claim 8] The apparatus according to claim 1, wherein the extension assembly includes an extension control that electrically communicates with at least one of the control unit and the vibration assembly, the extension control being configured to (a) determine the insertion load of the extension actuator, and (b) transmit the signal indicating the insertion load to one of the control unit and the vibration assembly. [Claim 9] The apparatus according to claim 1, further comprising a positioning device supporting the vibration assembly and the stretching assembly, the device further comprising a surface proximity sensor disposed outside the positioning device and electrically communicating with the control unit, the surface proximity sensor being configured to detect contact between the positioning device and the surface of the tissue and to provide the control unit with a signal of the detected contact.

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