JP2023520556A - Apparatus and method for automatic insertion of penetrating members - Google Patents

Abstract

An automatic insertion device and method of use thereof are provided. The vibrator and stretcher are connected to the penetrating member and both are in electrical communication with the controller. A detector identifies a subcutaneous target for insertion and an insertion angle. Penetrator distance and trajectory are calculated. A vibrator imparts vibrations to the penetrating member and a 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 loads encountered by the vibrator during insertion, and adjustments to the vibrations experienced by the stretcher during insertion. Based on insertion load feedback. Repeated samples are taken and the operation of one motor is constantly adjusted based on the operation of the other motor and the feedback from the other motor. [Selection drawing] Fig. 2

Description

This application is a co-pending U.S. application filed on September 16, 2016 claiming the benefit of now-defunct U.S. Provisional Application No. 62/220,567, filed on September 18, 2015 No. 15/267,801, a continuation-in-part application, the entire contents of which are incorporated herein by reference.

The present invention is generally useful for penetrating tissue within the body by automated means for the delivery or removal of bodily fluids, tissues, nutrients, pharmaceuticals, therapeutics, and medical devices (e.g., guidewires, catheters, etc.). device for obtaining percutaneous access to body compartments (eg, vasculature, spinal cavity, etc.) for secondary placement of .

Central venous catheters (CVCs) allow access to the central circulation of medical patients. More than 5 million CVCs are installed in the United States each year. CVCs are an important platform for initiating many important medical interventions for patients with acute illness and those requiring major surgery or procedures. There are more than 15 million days of CVC use per year in US hospital intensive care units (ICUs) alone, and 48% of ICU patients have a CVC inserted at some point during their ICU stay. CVC is used for acute renal failure, plasmapheresis for various immune-mediated diseases, multiple forms of chemotherapy for cancer patients, parenteral nutrition for patients unable to use the gastrointestinal tract for nutrition, and other It is also necessary for patients requiring urgent hemodialysis, including many medical interventions.

CVC placement has been performed since the 1950s using the homonymous technique developed by Swedish radiologist Sven-Ivar Seldinger. Using this technique, a hollow needle, also called an introducer needle, is advanced through the patient's skin and subcutaneous tissue, ultimately reaching a central vein located millimeters to centimeters below the skin surface. "Central veins" are the internal jugular, subclavian and femoral veins. Once in the central vein, a wire is manually placed through the hollow-bore needle into the vein. The needle is then removed and a coaxial tissue expander, often made of plastic, is threaded into the vein over the wire and removed from the wire. This stretches the tissue around the wire to allow a smooth passage of the CVC, which is then placed over the wire and inserted into the vein. Once the CVC is in place, the wire can be removed, leaving the CVC in the vein.

Since the Seldinger technique was first described, the standard guide for where to place the introducer 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 specific 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 superficial anatomy are 35% and 21%, respectively, in respected studies. It has been reported. These failure rates are due to the fact that surface anatomy cannot reliably predict the location of deep central veins in all patients. In 1986, ultrasonography (US) was used to visualize veins beneath the skin surface, and such images were used to more accurately guide manual placement of CVCs. Use of this technique has reduced CVC placement failure and complication rates to 5-10%. However, successful execution of the ultrasound-guided CVC placement technique requires sufficient training and experience. As such, general and cardiovascular surgeons, anesthesiologists, critical care physicians, and interventional radiologists are typically required to place these catheters. Unfortunately, these professionals are often unable to accommodate CVC placements in the frequently needed emergency or emergency timeframes.

Even well-trained and experienced providers may fail to place CVCs at the same rate due to unexplained or uncontrollable factors given the current state of insertion technology. The two main factors are tissue deformation and vein wall deformation. When the introducer needle is pushed into the skin or subcutaneous tissue, the force can dislodge the central venous target from its original position, causing a so-called "needle miss". Once the needle reaches the vein wall, it pushes the vein into another position called "rolling" which can again cause needle mispassing. Needle mispassing can cause the needle to hit critical structures near central veins, such as arteries, lungs, or nerves, which can lead to serious complications. The vein wall is also compressed by the force of the needle, collapsing the vein, making it nearly impossible to enter the lumen of the vessel, and usually facilitating passage of the needle through the posterior wall of the vessel. This is a phenomenon called "venous blow". A venous blow usually causes bleeding into the perivenous tissue. Bleeding is not only a significant complication of its own, but also disrupts the topographic anatomy and usually hampers subsequent successful CVC placement.

Accordingly, there is interest in various alternative systems for CVC placement, including automated systems that can be operated by clinicians or medical personnel. Such a system may allow for more widely available, reliable, and rapid placement of CVCs while reducing the potential for complications. However, to this point most research has focused on steerable needles to solve the fundamental challenges of tissue and vessel deformation. However, no satisfactory automated CVC placement system has been developed.

Automated insertion devices, systems, and methods are disclosed that combine actuation position guidance for target placement with vibration of a penetrating member, such as a needle, to penetrate skin, subcutaneous tissue, and vein walls, and to penetrate the needle. Alleviates problems of tissue and vessel wall deformation that plague insertion. The devices and systems include a series of mechanical actuators that direct the path of the penetrating member or needle, followed by a processor that calculates and directs the positioning and path of needle placement. Various actuators can be automated to operate under the direction of a processor. Although described as being used for automated insertion of penetrating members such as needles, the same devices and systems are used to insert additional medical devices, including guidewires and catheters, into any body cavity, vessel, or compartment. can do.

The insertion device employs the use of certain vibration penetrating members. Previous studies have demonstrated that vibrating the needle during insertion reduces both puncture and frictional forces. This phenomenon is exploited in nature by mosquitoes to vibrate their proboscis to penetrate the host's skin. Increased needle velocity due to vibration reduces tissue deformation, energy absorption, penetration forces, and tissue damage. Some of these effects are due to the viscoelastic properties of living tissue and can be understood through a modified nonlinear Kelvin model that captures the force-deformation response of soft tissue. Since the deformation of the internal tissue of the viscoelastic body depends on the speed, increasing the needle insertion speed reduces the deformation of the tissue. Reducing tissue deformation before crack propagation increases the rate at which energy is released from the crack and ultimately reduces the force of rupture. The reduction in force and tissue deformation with increased needle insertion speed is particularly pronounced in tissues with high water content such as soft tissue. In addition to reducing the force associated with cutting into tissue, studies have also shown that vibration of the needle during insertion reduces frictional forces between the needle and surrounding tissue.

Thus, applying vibratory motion, also referred to herein as vibrating and/or reciprocating motion, to the needle during insertion reduces three challenges in advancing the needle tip to a desired position compared to using a static needle: can be overcome. First, the vibration minimizes tissue deformation between the skin and the target vein. This tissue deformation and the "pop-through" that occurs when the needle tip traverses different tissue layers can cause the target to move relative to the planned path of the needle. Second, the vibrating needle reduces rolling of the target vein. Third, the vibrating needle provides additional contrast to the ultrasound image, allowing the user to observe the advancing needle and final placement position. 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.

The system also provides a way to change the target point prior to deploying the penetrating member. When the target point is changed, the processor recalculates and updates the penetrating member's position information and provides updated adjustment data for the various actuators to align the penetrating member with the new target point. . Imaging can be used with the insertion device so that an image of the subcutaneous area can be visualized for the user to see. Target points can be selected and updated by the user on the display for interactive control.

The insertion device may also be handheld for ease of use by the practitioner or user.
In certain embodiments, the automated insertion device includes a vibrating assembly and a tensioning assembly in electrical communication with each other and/or with a controller or processor. The vibratory assembly includes a vibratory actuator that, when actuated, produces axial vibrations and imparts or transmits these vibrations to the connected penetrating members. The stretching assembly includes a stretching actuator directly or indirectly connected to the penetrating member to move the penetrating member along the insertion axis to insert the penetrating member to a desired preselected target within the target tissue. be able to. The insertion distance is calculated or calculated by a controller or processor based on image data from a detector such as an ultrasound probe positioned to detect the subcutaneous target site and provide visualization or three-dimensional coordinates of the target site. can be determined. The insertion angle of the penetrating member can also be adjusted based on the target information and/or the image data from which the target information is derived.

During operation, the vibration actuator axially vibrates the penetrating member according to the operating parameters of the actuator. While vibrating, the extension actuator advances the penetrating member along the insertion axis a determined distance to reach the target site. Vibration actuators and extension actuators operate in their initial modes by default. During insertion, the load on the vibration and extension actuators is monitored at intervals, such as every few milliseconds. When the load and/or power consumption of a vibration or extension actuator changes by a predetermined amount, control signals can be sent to other actuators to change their operating parameters to compensate. For example, the extension actuator may employ different modes of operation with faster or slower insertion speeds depending on the load on the vibration actuator. Similarly, control signals are sent to the vibration actuators to change vibration parameters such as power, amplitude and/or frequency of vibration to higher or lower power, amplitude or frequency depending on the load on the extension actuator. different vibration modes can be adopted. In the event of further deviations from the predetermined values of the load and/or power consumption of the vibration actuator and/or the extension actuator, additional A signal may be transmitted. This is the increase or decrease of one motor or actuator to compensate for the decrease or increase, respectively, of the other motor or actuator. Each determination of whether the deviation of the load and/or power consumption of the vibration or extension actuators has exceeded a respective predetermined value is based on the recently detected load and/or power consumption levels, or the initial start-up load and power consumption of each actuator. /or based on or compared to power consumption levels.

Thus, there may be numerous insertion speeds and modes of operation, which are automatically adjusted throughout the insertion process depending on vibration and/or tension actuator load and/or power consumption. The vibration and tension actuators 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. act collectively, responsively, and automatically to This avoids the problem of tissue deformation that previously plagued practitioners.

Thus, the insertion speed and vibration rate are not constant throughout the insertion process. Rather, it can speed up or slow down based on inputs from other motors. If one motor "stuck" (e.g., consuming increased power beyond a pre-defined amount as a result of excessive resistance during tissue penetration), the other motor would adjust. Compensate. For example, if the vibration actuator is vibrating at a reduced amplitude, the insertion speed of the extension actuator can be reduced. Conversely, if the penetrating member is vibrating without problems, the extension actuator may operate at maximum insertion velocity. Vibration can also be adjusted based on the operation of the extension actuator. When the tension actuator begins to draw excessive power, indicating that it is encountering excessive resistance during tissue penetration, this input is transferred to the vibration actuator, triggering a change to a more aggressive vibration mode. , to help penetrate denser tissue. This communication between the extension actuator and the vibration actuator, whether occurring directly or indirectly through the processor, is bi-directional.

The insertion device and method, together with particular features and advantages thereof, will become more apparent by reference to the following detailed description and accompanying drawings.

1 is a perspective view of one embodiment of an insertion device of the present invention; FIG. 2 is a side view of the insertion device of FIG. 1 and a schematic diagram of the arrangement for use; FIG. 1 is a schematic diagram of a system for inserting a penetrating member; FIG. 3 is a side view of the insertion device of FIG. 2 showing adjustment of the handle; FIG. 3 is a plan view of the insertion device of FIG. 2 showing adjustment of the sidearm for positioning; FIG. FIG. 3 is a schematic diagram of an insertion device showing dimensions used in calculations by a processor; FIG. 4 is a schematic diagram showing a target area used for calculations by a processor; 1 is an exemplary ultrasound display for use in visually adjusting an insertion device; 2 is a side view of the insertion device of FIG. 1 showing a schematic representation of various adjustments directed by the processor for automatic insertion; FIG. 7 is a perspective view of the insertion device of FIG. 6 partially cut away to show the various actuators; FIG. FIG. 11 is a side view showing vertical adjustment by a vertical actuator; FIG. 10 is a side view showing vertical adjustment by a vertical actuator; FIG. 10 is a partial cutaway view showing one embodiment of a vertical actuator for vertical adjustment; FIG. 4 is a side view showing angle adjustment by an angle actuator; FIG. 4 is a partially cutaway view of one embodiment of an angular actuator for angular adjustment; FIG. 4 is an exploded view of the portion of the insertion device with the angular actuator showing the keying relationship of the angular actuator from opposite directions; FIG. 4 is an exploded view of the portion of the insertion device with the angular actuator showing the keying relationship of the angular actuator from opposite directions; FIG. 11 is a side view showing adjustment by linear stretching; FIG. 12 is a partial cutaway view showing one embodiment of a tension actuator for tensioning. FIG. 4 is a top view in partial cross section showing the extension actuator and connected extension shaft in the retracted position; 15B is a top view in partial cross section showing the extension actuator and connected extension shaft of FIG. 15A in an extended position; FIG. FIG. 10 is a partial cutaway view showing one embodiment of a vibration actuator for vibratory motion; FIG. 3 is a cross-sectional view of one embodiment of a vibration actuator for vibrational motion; FIG. 10 is a perspective view of another embodiment of an insertion device including a guidewire for insertion; 18 is a partially cutaway perspective view of the embodiment of FIG. 17 showing a guidewire actuator for guidewire placement; FIG. 18 is a perspective cut-away view of the embodiment of FIG. 17 showing positioning of a guidewire through the insertion device; FIG. 18 is a perspective view of one embodiment of the embodiment of FIG. 17 showing the guidewire housing attached; FIG. 19B is an exploded view of the embodiment of FIG. 19A showing the guidewire housing removed; FIG. FIG. 10 is a perspective view of another embodiment of an insertion device in which reciprocating and vibration actuators are aligned with a penetrating member; 20B is a partial cross-sectional view of the embodiment of FIG. 20A showing the guidewire passing through the vibration actuator; FIG. Figure 2OB shows a close-up of the cross-section of Figure 2OB; FIG. 10A illustrates a perspective view of one embodiment of an in-line housing with side ports. 21B is a cross-sectional view of the embodiment of FIG. 21A; FIG. FIG. 11 shows another embodiment of a neck with multiple side ports; Fig. 10 is a perspective view of another embodiment of the automatic insertion device of the present invention, shown in the retracted position; 24 is a perspective view of the insertion device of FIG. 23, shown in the extended position; FIG. Figure 24 is a perspective view of the insertion device of Figure 23, showing the proximal end of the device; FIG. 11 is a schematic diagram of one embodiment of an automatic insertion device showing the interconnecting motion of the tensioning assembly and the vibrating assembly; FIG. 2 is an electrical flow diagram illustrating one embodiment of the operation of the device; FIG. 2 is a schematic representation of the steps of a method of operating an autoinsertion device;

Like reference numbers refer to like parts throughout the several views of the drawings.

As shown in the accompanying drawings, the present invention is an insertion device that allows subcutaneous access to body cavities such as blood vessels for the insertion of needles and potentially the placement of guidewires, dilators, catheters such as CVCs, and the like. Apparatus, systems and methods. The devices and systems include multiple actuators that can be automated to adjust the position and deploy the penetrating member within the target tissue, such as the patient's skin. A target point is preselected and used to calculate the position and alignment of the penetrating member, and a series of actuators are adjusted to control the various components of the device to reach the preselected target position during deployment to generate the proper alignment. The actuator may be automatically adjusted based on calculations made by the processor, and may be further adjusted when the position of the target point is changed. In at least one embodiment, image-based modalities are used to acquire data about the targeted tissue or cavity. For ease of use, it is desirable that the entire device be handheld.

The insertion device 100 as shown in the embodiment of FIGS. 1 and 2 includes a detector 20 for obtaining data and information about the tissue of the subcutaneous region and using this data, based on the calculated parameters , a processor 22 for calculating various positioning and adjustment parameters for a penetrating member 10, such as a needle, which may be an introducer needle, for insertion at a desired preselected target point 29 within tissue. . Target point 29 may be any point located subcutaneously within the patient's body, such as a blood vessel. Identifying target vessels is a typical skill of many medical professionals trained in the medical industry. However, guiding the needle to its target is difficult given the complications and risks to the patient from tissue deformation and vein rolling.

In at least one embodiment, insertion device 100 allows a user to obtain information about a target vessel within tissue through an imaging modality such as ultrasound and select a target point 29 on display 24 showing a corresponding image of the vessel. be able to. The target point 29 can be adjusted by the user on the display 24, such as on a touch screen, and the processor 22 determines how the tip of the penetrating member needs to move from its current position to reach the target location within the patient's body. Automatically calculate resulting heights, trajectories, angles, and distances. Using these calculations, processor 22 provides operational data or instructions to various actuators 32, 42, 52 of positioning device 120 to move the tip of penetrating member 10 in various directions in an automated manner. , to reach the desired position ready for deployment. Each actuator 32, 42, 52 may include sensors that transmit position information to processor 20 for use in making adjustment calculations. Once the desired position is achieved, the device 100 can be activated to deploy the penetrating member 10 and advance it the calculated distance. Processor 22 may also instruct penetrating member 10 to automatically stop when penetrating member 10 reaches a preselected target point 29 so that penetrating member 10 does not pass target point 29 . . The processor also directs the vibratory actuator 62 to initiate vibratory motion, such as reciprocating motion, in the penetrating member 10 during deployment to overcome tissue deformation and vein rolling complications typically encountered with needle insertion. and can guide.

As seen in FIG. 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 the detector 20 . In some embodiments, these data are images obtained by detector 20, which can be an image detector. The subsurface tissue data is transmitted to the processor 22, which calculates the distance between a preselected target point 29 within the tissue or body cavity and the tissue surface. Calculation software, logic circuitry, etc., of processor 22 uses this calculated distance to calculate adjustment data for vertical actuator 32, angular actuator 42, and extension actuator 52, and uses this data to translate penetrating member 10 movement. to the corresponding actuator. Processor 22 also determines vibration data for vibration actuator 62 based on operating parameters of vibration actuator 62 and transmits this data to vibration actuator 62 to actuate vibration actuator 62 to induce vibration or reciprocating motion in penetrating member 10 for deployment. Let Transmission of data to the various actuators 32 , 42 , 52 , 62 and their actuation can occur in any order, or in a predetermined or prescribed order, as indicated by processor 22 . Penetrating member 10 may be automatically deployed based on extension adjustment data sent to extension actuator 52 . In some embodiments, the user determines when proper positioning of the penetrating member 10 has been reached for alignment with the projected path to intersect the target point 29, and he/she directs the processor to 22 and relayed to an extension actuator 52 that extends the penetrating member 10 a pre-calculated distance to a target point 29 under the skin based on information from the acquired image. can.

In some embodiments, detector 20 is an image detector, such as an ultrasound probe or other transceiver. Data obtained by the detector 20 can be presented on a display 24 that can be viewed by a user. A representation of the preselected 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, a user can interact with an image or representation on display 24, such as via an interactive touch screen or joystick, to move representative target point 29' on display 24. As representative target point 29' moves on display 24, processor 22 provides updated adjustment data for vertical actuator 32, angular actuator 42, and extension actuator 52 based on the new representative target point 29'. calculate. 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 deploy the penetrating member 10 for insertion and respond A command is sent to the extension actuator 52 to do so.

In use, insertion device 100 is placed along or adjacent to tissue, such as a patient's skin, to locate a target vessel, such as a vein. In at least one embodiment, as in FIGS. 1 and 2, the device 100 is handheld and includes a handle 21 that can be grasped by a user, such as a clinician or medical personnel. The handle 21 can be ergonomically shaped to improve efficiency and comfort, especially when held for long periods of time if desired. Handle 21 is preferably grasped by the user's non-dominant hand, such as the left hand of a right-handed person, so that the dominant hand is available for target location selection and deployment of device 100 . Thus, the device 100 can be used equally by right-handed and left-handed individuals and is not grip orientation specific. Indeed, in some embodiments, the handle 21 is rotatable about an axis to accommodate different grip orientations or positions, or to acquire different image views when imaging, as shown in FIG. 4A. can be done.

In at least one embodiment, the insertion device 100 also includes a support 27 that can be placed on the user's elbow, shoulder, arm, or chest. Support 27 provides the user with additional stability when positioning and using device 100 . As shown in FIG. 4B, the support 27 may be spaced from the handle 21, such as by a side arm 26 corresponding to the user's arm, and may be adjustable in length to reach the user's hand. . The sidearm 26 is aimed at the blood vessel, as indicated by the directional arrows in FIG. It may be moveable within an arcuate path while properly aligning as needed to do so. The range of motion of the side arm 26 is up to 360°, thus allowing any desired approach angle. For example, the user can sit or stand perpendicular to the desired target vessel adjacent to the patient and still use the insertion device 100 to align and position the penetrating member 10 with the target vessel. The full range of motion of the sidearm 26 may also allow switching from right-handed to left-handed use.

Insertion device 100 includes a detector 20 near, adjacent to, or even in contact with the area of the patient to be imaged, as shown in FIG. In at least one embodiment, the detector 20 is positioned at the distal end of the handle 21 such that the detector 20 can be positioned along the patient's skin or other tissue 5 by moving the handle 21 over the patient. be done. Detector 20 obtains information or data about the surrounding area, such as the subcutaneous area, and can include location information of tissue 5, cavity 7, and other structures therein. In at least one embodiment, the detector 20 is used for imaging to visualize a subcutaneous or percutaneous region of the patient, also called a target region 28 as shown in FIG. It is of modality. The imaged target region 28 can be of any shape, volume, or depth D, as can be produced by the particular imaging modality. The imaging modality may be any suitable form of imaging subcutaneous regions of the patient, such as, but not limited to, ultrasound, computed tomography, and magnetic resonance imaging. In a preferred embodiment, ultrasound is useful for its ability to provide images that clearly distinguish between tissue 5 and body cavities 7, such as the interior of blood vessels beneath the surface of the skin, as shown in FIG. 5C. . As used herein, "tissue" may refer to any tissue or organ of the body, and specifically refers to any substantial substance having mass. For example, tissue may equally refer to skin, muscle, tendon, fat, bone, and organ wall. In contrast, "body cavity" as used herein may refer to a cavity, open interior, lumen, or volume of space within a tissue or organ such as a blood vessel, vein, artery, or the like.

Thus, in at least one embodiment, detector 20 is an ultrasound transducer that emits and receives ultrasound waves through the patient's skin and tissue for visualization. Although typical B-mode ultrasound imaging can be used with detector 20, Doppler ultrasound can also be used to distinguish blood flow in different directions. Linear or curvilinear ultrasound transducers are preferred, although sector phased arrays may be used in some embodiments. The ultrasonic detector 20 can operate in the frequency range of 3-15 MHz, but more preferably operates in the range of 6-10 MHz, as the depth of penetration is inversely proportional to frequency. Provides good contrast between depth of penetration. For accurate placement of penetrating member 10, very accurate measurement of pixel size is important, as pixel size is related to the distance or phase velocity of sound in tissue. The ultrasound detector 20 operates in either the long-axis image plane view, where the vessels are viewed longitudinally, or the short-axis view, where the vessels are viewed in cross-section and appear as circular structures in the resulting image as shown in FIG. 5C. can be In at least one embodiment, short-axis view imaging 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 the depth of the vessel to be seen in order to determine the optimal placement of the target point 29 so as not to blow out the vein or vessel. In either scheme, the image plane produced by detector 20 is known for the various actuators described below for proper positioning accuracy and alignment of the ultrasound image and the spatial coordinates of penetrating member 10. at an angle.

Insertion device 100 further includes processor 22 in electronic communication with detector 20 to receive data obtained by detector 20 regarding the position of tissue 5 and cavity 7 therein. In some embodiments, these data are arranged as images of the subcutaneous area obtained by the detector 20 and presented to the processor 22 and display 24 (as shown in FIGS. 1 and 2 for visualization by the user). screen that presents images, etc.). FIG. 5C shows an example of an ultrasound image acquired by detector 20 presented on display 24 . Display 24 also shows a pictorial representation of target point 29', such as with crosshairs, target markers, or other symbols, in conjunction with the image from detector 20. FIG. The image of representative target point 29' on display 24 may be moved up or down on display 24 by the user. As the representative target point 29' moves, the positioning of the penetrating member 10 is adjusted as described below, and this can be done automatically and in real time. The display 24 shows parameters of the detector 20 (such as the frequency used), screen resolution, magnification, measurements or position information from various components of the positioning device 120 (discussed in more detail below), and the insertion device 100 Additional information can be displayed including, but not limited to, buttons or areas for activating various components of the .

Display 24 may be a passive screen or an interactive screen. In at least one embodiment, display 24 is a touch screen that can operate through resistive, capacitive, or other tactile feedback mechanisms. For example, representative target point 29' on display 24 may be selected, such as by sliding a finger, thumb, or selection device along display 24 in a continuous path, or by selecting a new location for representative target point 29'. It may be movable by touching on the touch screen by touching discrete locations on the display 24 screen to do so. In some embodiments, the display 24 and processor 22 may be removably connected to the insertion device 100 via a wireless protocol such as Bluetooth or via a wired multi-pin connector, smart phone, personal information It may be contained in a single device such as a terminal (PDA), or a tablet computer. In other embodiments, display 24 and processor 22 are included in a single device that can be integrated with the rest of insertion device 100 . In a further embodiment, the processor 22 is an integral component of the insertion device 100 and may be located within the housing 23 as in FIG. 1 and the display 24 is separately removable from the rest of the insertion device 100. may be

In other embodiments, display 24 is a passive screen, such as a monitor, and device 100 includes a joystick or directional button(s) ( not shown). The joystick or directional buttons can output directional signals to the processor 22 based on the orientation and tilt of the joystick lever or the particular directional button pressed or selected. Output signals from the joystick or direction buttons control the position of a representative target point 29' such as a crosshair shown on display 24 such that the image of target point 29 is superimposed on the target location. In some embodiments, the joystick or directional buttons may be positioned on or near the display 24, such as along the edges of the monitor's frame. In other embodiments, a joystick or directional buttons can be placed on the handle 21 to allow one-handed operation of the device 100 for imaging.

The processor 22 electrically communicates with the display 24 regarding the position and position changes of the desired target point 29 as indicated by the user from interaction with a representative target point 29' on the display 24, such as by touch screen interaction. Communicate and receive information from the display 24 . Processor 22 may be programmed, software, logic, or otherwise to calculate how to adjust penetrating member 10 from its existing position to a position to reach target point 29 indicated by user-directed information provided from display 24 interaction. including computing power.

For example, FIG. 5A shows a schematic diagram of insertion device 100 showing various dimensions used in calculations by processor 22 . Some of these dimensions are fixed dimensions of device 100 . For example, H is the height of handle 21 from detector 20 to the center of main arm 25 . Distance A is the length of main arm 25 from the center of handle 21 to the center of positioning device 120 , such as vertical actuator 32 . In some embodiments, A is of fixed length, such as when primary arm 25 is of fixed length. The size of the mounting portion of the penetrating member 10 and the length of the piercing 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 penetrating member 10 and the angle adjustment 30 also remains fixed.

Other dimensions of computation differ. For example, D is the distance between the detector 20 located at the surface of the tissue 5 or skin and the target point 29 within the body cavity 7, such as inside a blood vessel under the skin. Therefore, D is which vessel is used as a target, the amount of tissue that exists between the target vessel and the skin or surface on which the detector 20 is placed, as well as the location of the target vessel and the fullness of the vessel. Or depending on the degree of compression, which varies from patient to patient. In at least one embodiment, the height L of the positioning device 120 can vary. In some embodiments, the height L of FIG. 5A can be preset prior to use such that the insertion device 100 is fixed during use. Using this information, the microprocessor can determine the tilt angle θ _D and the distance P from the tip of penetrating member 10 to target point 29 using Pythagorean theorem and trigonometry. For example, here's how to perform the calculations:

Alternatively, the angle θ _D can be preset by the user and the height L and distance P can be calculated using similar mathematical relationships.
Viewed another way and still 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 penetrating member 10, and D and Form a right angle with another leg. The insertion distance of the penetrating member 10 is P, which is the oblique side of the triangle, and is calculated by solving P in the following equation.
^D2 + ^X2 = ^P2
Therefore, the insertion angle θ _D is calculated as follows.

Therefore, there are many ways to perform computations based on known constant dimensions and variables. The above are only examples. In other embodiments, height L can be adjusted and automated during use of insertion device 100, such as when a shallow or acute angle _θD is desired. This is the case when the target vessel itself is very shallow or partially collapsed, or is below the surface of the skin. In such exemplary embodiments, the height L may be increased to position the penetrating member 10 to reach the target point 29 in order to achieve the proper angle. The amount of increase or decrease in height L is calculated in real time by the processor of processor 22 . This is because angle θ _D is also calculated for adjustment based on information entered by the user at display 24 . For example, as the user slides his finger up along the display 24, the target point 29 indicator also moves up and the angle θ _D becomes shallower or sharper. Conversely, when the user slides the finger down along the display 24, the target point 29 indicator also moves down, increasing or deepening the angle _θD . Sliding a finger along touch screen display 24 is just one embodiment. In other embodiments, a knob or dial can be used to move representative target point 29' up or down on the screen, which corresponds to adjusting angle θ _D as determined by processor 22. .

Processor 22 is also in electrical communication with positioning device 120 that is spaced from imaging assembly 110 of insertion device 100 , such as by main arm 25 . Primary arm 25 may be of any suitable length sufficient to space penetrating member 10 from detector 20 such that penetrating member 10 can approach and reach a desired target point 29 . Main arm 25 is adjustable manually or automatically, such as by an actuator, but in at least one embodiment is stationary and fixed in length.

1, 2 and 6, the positioning device 120 has a vertical adjustment 30 that adjusts the penetrating member 10 in a vertical direction 31 and an angular adjustment that adjusts the tilt angle of the penetrating member 10 along an angular direction 41. 40 and an extension adjustment 50 that moves the penetrating member in a linear direction 51 toward or away from the target point 29 for insertion and removal. A vibrator 60 that provides reciprocating motion in longitudinal direction 61 along penetrating member 10 is also present in insertion device 100 but need not be a component of positioning device 120 . As seen in FIG. 7, each of the adjustment parameters is affected by actuators 32, 42, 52, 62 which receive signals from processor 22 that provide instructions regarding the movement parameters. , and can automatically move according to their instructions to adjust the positioning of the penetrating member 10 .

For example, referring to FIGS. 7-9, vertical adjustment 30 provides a mechanism for raising and lowering attached penetrating member 10 . Specifically, vertical adjustment 30 includes a vertical actuator 32 in electrical communication with processor 22 to receive vertical adjustment data for activation and movement. Upon receiving signals or data from processor 22, vertical actuator 32 operates and moves in accordance with vertical adjustment data calculated by processor 22 to position the skin or other tissue perpendicular to the surface of the skin or other tissue being imaged for insertion. Adjust the penetrating member 10 in direction 31 . Vertical actuator 32 may be a motor that rotates or acts on a shaft. For example, in at least one embodiment, as shown in FIG. 9, vertical actuator 32 is a rotary motor that rotates pin 35 extending from vertical actuator 32 . Pins 35 engage tracks 34, such as in an interlocking manner between corresponding teeth or grooves on pins 35 and tracks 34, like a rack and pinion system. Rotation of pin 35 in one direction causes its extensions to engage extensions of track 34 to move track 34 up and down in vertical direction 31 . When vertical actuator 32 rotates pin 35 in the opposite direction, track 34 correspondingly moves in the opposite vertical direction. The vertical actuator 32 can thus be arranged perpendicular to the track 34 . The track 34 can be arranged within the vertical housing 33 . In other embodiments, track 34 may be a slide bar and vertical actuator 32 may move pin 35 along the slide bar between different locking positions to move the slide bar vertically. . In still other embodiments, vertical actuator 32 may be a linear motor positioned along vertical direction 31 and, when actuated, extends pin 35 or other elongated shaft, thereby causing housing 33 to move vertically. Go to 31. As noted above, in some embodiments, vertical actuator 32 may be automated by processor 22 to move in real-time as adjustments are made to target point 29 on display 24 . However, in some embodiments the vertical actuator 32 may not be actuated, such as when no adjustment in the vertical direction 31 is required or when the vertical height component is intended to be fixed.

Positioning device 120 also includes angle adjustment 40, as shown in FIGS. 7 and 10-12B. Angular adjustment 40 includes an angular actuator 42 in electrical communication with processor 22 . Angular actuator 42 receives signals, such as angle adjustment data, from processor 22 and provides instructions for actuation to change the angle of inclination of penetrating member 10 . The tilt angle can be any angle between 0° and 180° with respect to the surface of the tissue. In at least one embodiment, the tilt angle is an acute angle between 0° and 90°. The tilt angle is adjusted in angular direction 41 as seen in FIG. 10 according to calculations performed by processor 22 . Therefore, the entry angle can be shallow or steep, as determined by the user. In the imaging embodiment, when the user moves the representative target point 29' up or down on the display 24, a corresponding signal is relayed from the processor 22, and the processor 22 updates the calculations so that the representative target point 29' ' determines updated or new angle adjustment data based on the new position of '. This updated data is sent to angular actuator 42, which activates and adjusts the angle of penetrating member 10 accordingly, which may be in real time. This activation is automated by processor 22 . Angle actuator 42 may be a motor suitable for changing the tilt angle. In a preferred embodiment, angular actuator 42 is a rotary motor that rotates when actuated. In such embodiments, the shaft 43 extends from the angular actuator 42 into the receiver 45 or other structure that is free and movable independently of the angular actuator. Shaft 43 and corresponding receiver 45 are closely fitted, complementary keyed, etc. such that rotation of shaft 43 imparted by angular actuator 42 correspondingly rotates mating receiver 45. , can be of corresponding shape.

For example, in the embodiment of FIGS. 11, 12A, and 12B, shaft 43 has a keyed configuration such that it has an irregular shape, such as having a flat surface along one side of an otherwise cylindrical shape. . Receiver 45, through which 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 angular actuator 42, the particular shape engages the corresponding shape of the receiver 45, transmitting rotational motion to the receiver 45, which in turn rotates the receiver 45 as well. Since the receiver 45 is an integral component of the positioning device 120 separate from the angular actuator 42, the rotary motion transmitted to the receiver 45 by corresponding geometrical interaction with the shaft 43 is shown in FIG. As such, the remainder of the positioning device 120 is also rotated. Angular actuator 42 may be surrounded by angular motor housing 44, which may include an opening through which shaft 43 extends, as seen in FIGS. 11 and 12A.

Positioning device 120 further includes stretcher 50 shown in FIGS. 7 and 13-15B. Stretcher 50 includes a stretch actuator 52 in electrical communication with processor 22 to receive stretch adjustment data and instructions regarding actuation and travel distance. When the data is received, extension actuator 52 is actuated to move penetrating member 10 in linear direction 51 , as seen in FIG. 13, by a predetermined distance calculated by processor 22 . In at least one embodiment, as shown in FIGS. 13-15B, the extension actuator 52 is a linear motor, although other forms of motor may be used to effect movement of the penetrating member along the linear direction 51. may

The stretcher 50 also includes an extension shaft 53 extending from the extension actuator 52 to an oppositely located extension mount 54 located on a separate component of the positioning device 120 . Extension shaft 53 may be fixed to or integrally formed with extension actuator 52, extension mount 54, or both. The extension shaft 53 may be retracted or housed within the extension actuator 52 or may share a common housing and may be pushed out of the housing by the extension actuator. In some embodiments, as shown in FIG. 13, the elongate shaft 53 may be a telescopic shaft. In other embodiments, as in Figures 15A and 15B, the extension shaft 53 may be a uniform bar or elongated member that moves in and out of the extension actuator 52 upon actuation. The distance that the extension shaft 53 is pushed out of the extension actuator 52 is indicated and calculated by the processor of the processor 22 based on the target point 29 positioning information entered by the user on the display 24 . The elongated shaft 53 is made of a rigid material such that movement of the elongated shaft 53 causes corresponding movement of the elongated mount 54 to which it terminates. In this way, the penetrating member 10 is moved a calculated distance in the linear direction 51 by the extension actuator 52, as shown in FIG.

In some embodiments, the extension actuator 52 is used to move the penetrating member 10 a calculated distance, such as by moving the penetrating member 10 such that the tip of the penetrating member 10 contacts the patient's skin or tissue 5 . just move it to align or position it for use. In other embodiments, extension actuator 52 is used to deploy penetrating member 10 such that the tip of penetrating member 10 moves from the ready position to the position of target point 29 . In at least one embodiment, extension actuator 53 is used to align and deploy penetrating member 10 in a linear direction toward target point 29 . Both alignment and deployment of the penetrating member 10 can be automated. In at least one embodiment, deployment of the penetrating member 10 is independent of alignment and positioning of the penetrating member 10 in various other dimensions by placement of the detector 20 and operation of the vertical and angular actuators 32, 42 by the user. Activation of a button or a particular area of the display 24, such as a soft button or virtual button on a touch screen, or a button on a joystick or other component that may be actuated at any time.

Insertion device 100 also includes vibrator 60, as shown, for example, in FIGS. 7, 16A and 16B. Vibrator 60 includes a vibration actuator 62 in electrical communication with processor 22 from which vibration data indicating when to activate and the amount of vibration actuator 62 to be used is determined by processor 20 and may be based on various factors. type and operating parameters to use, including but not limited to the type and condition of the tissue 5 to be penetrated. Upon actuation, vibration actuator 62 provides repetitive reciprocating or oscillating motion to penetrating member 10 back and forth along longitudinal direction 61 . Longitudinal direction 61 coincides with the axis of penetrating member 10 . As used herein, the terms “reciprocating,” “oscillating,” and “vibrating” can be used interchangeably and refer to longitudinal direction 61 that is coincident or parallel to the length of penetrating member 10 . refers to the forward and backward movement of the

Upon receiving an activation signal from processor 22, vibration actuator 62 is turned on. Activation may occur automatically, or only at some point during the insertion process, such as when the penetrating member 10 is properly positioned and aligned but before it is deployed for insertion. Accordingly, actuation of vibration actuator 62 may occur only when proper positioning of penetrating member 10 is confirmed by the user in some embodiments, or may begin automatically once target point 29 is aligned. can be done.

Vibrator 60 includes a drive shaft 68 that extends from vibration actuator 62 to a coupler or housing connected to penetrating member 10 . Drive shaft 68 transmits the mechanical vibrational motion generated by vibration actuator 62 to penetrating member 10 . The vibrator 60, and thus the vibration actuator 62, may be axially offset from the penetrating member 10 in some embodiments, as in FIGS. 16A and 16B, or as in FIGS. may be in-line or coaxial with the

In at least one embodiment, vibration actuator 62 is axially offset from penetrating member 10, as shown in FIGS. 16A and 16B. Here, vibration assembly 60 includes a drive shaft 68 extending from vibration actuator 62 to drive coupler 69 . In some embodiments, drive shaft 68 extends at least partially within drive coupler 69 . The drive coupler 69 is adjusted by connecting it to the offset coupler 70 or the like. For example, at least a portion of drive coupler 69 may extend into offset coupler 70 and vice versa. Offset coupler 70 includes a hub 71 to which the proximal ends of penetrating members 10 connect, such as by threading, twisting, threading or keying or other suitable connection. Drive coupler 69 and offset coupler 70 extend perpendicular to drive shaft 68 and penetrating member 10 . Drive coupler 69 and offset coupler 70 thus collectively transmit the vibratory motion produced by vibratory actuator 62 and propagated by drive shaft 68 to penetrating member 10 along different parallel axes.

In at least one other embodiment, vibrator 60' and vibration actuator 62' of insertion device 100' are coaxial or in-line with penetrating member 10, as in FIGS. 20A and 20B. In such embodiments, the drive shaft 68' extends from the vibration actuator 62' to a portion of the housing 73. The housing 73 may also include a vibration actuator 62', which connects the distal end to which the penetrating member 10 connects to the hub 71. As shown in FIG. In some embodiments, housing 73 may further include a neck 74 extending between housing 73 and hub 71, such as when additional space is required.

Whether vibrators 60, 60' are offset or in-line with penetrating member 10, vibration of penetrating member 10 by vibration actuator 62 may be selected based on the type of tissue to be penetrated in a variety of ways. can be achieved with The specific actuation mechanism and insertion force that help overcome tissue deformation will depend on the resonant frequency and other electromechanical properties of the system, and the tissue, vessel, or other structure encountered by the advancing tip of penetrating member 10. interacts beneficially with resonances and other mechanical properties of

For example, in at least one embodiment, vibration actuator 62 is a piezoelectric motor. Transducer technologies that rely on conventional single or stacked piezoceramic assemblies for actuation 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 ceramic lead zirconate titanate (PZT) and 0.5% for single crystal piezoelectric materials, so a few millimeters or a few To approach ten microns of displacement or actuation would require extensive stacking of cells. Actuating components using large stacks of cells also requires increasing the size of the medical tool beyond the available biometric designs of handheld devices.

A flextensional transducer assembly design has been developed that provides amplification of the strain displacement of the piezoelectric material stack. A flextensional design includes a piezoelectric material transducer drive cell located within a frame, platen, end cap, or housing. The shape of the frame, platen, end caps, or housing amplifies the axial or longitudinal motion of the driver cell, resulting in greater displacement of the flextensional assembly in a particular direction. Basically, a flextensional transducer assembly more efficiently converts strain in one direction into motion (or force) in a second direction.

Thus, as shown in FIG. 16B, vibration actuator 62 is a flextensional transducer that includes multiple piezoelectric elements 63 stacked with electrodes 65 disposed between adjacent piezoelectric elements 63 . A piezoelectric laminate 64 is formed by laminating a plurality of piezoelectric elements 63 and electrodes 65 . An insulator 66 covers the ends of the stack 64 and shields the rest of the device from the energy produced by the piezoelectric element 63 . A rear mass 67 located on the opposite side of the insulator 66 applies tension to the piezoelectric stacks 64 and keeps the stacks 64 compressed together for increased efficiency. At least the piezoelectric laminate 64, preferably the insulator 66 and the rear mass 67, are similarly cylindrical with a hollow bore formed through the center. A drive shaft 68 extends through this hollow bore through vibration actuator 62 . When the electrodes 65 are electrically stimulated, e.g. when the vibration actuator 62 receives a signal from the processor 22 to operate, the electrical energy transmitted through the electrodes 65 is converted by the piezoelectric element 63 into mechanical vibration energy, It is then transmitted to drive shaft 68 to move drive shaft 68 in linear direction 61 in a repetitive oscillatory motion.

Various flextensional transducers are contemplated for use as vibration actuators 62, 62'. For example, in one embodiment, the flextensional transducer is of the cymbal type, as described in US Pat. No. 5,729,077 (Newham), incorporated herein by reference. In another embodiment, the flextensional transducer is an amplified piezoelectric actuator ("amplified of the piezoelectric actuator (APA) type. In yet another embodiment, the transducer is a Langevin or bolted dumbbell transducer similar to, but not limited to, those disclosed in U.S. Patent Application Publication No. 2007/0063618 A1 (Bromfield). , which is also incorporated herein by reference. FIG. 16B shows a particular example of implementing a Langevin transformer as vibration actuator 62 .

In one embodiment, the flextensional transducer assembly may utilize flextensional cymbal transducer technology, and in another example, amplified piezoelectric actuator (APA) transducer technology. can. The flextensional transducer assembly provides superior amplification and improved performance over conventional handheld devices. For example, amplification can be improved up to about 50-fold. In addition, the flextensional transducer assembly allows for a simpler design and smaller housing configuration. When electrically activated by an external electrical signal source, vibration actuators 62 , 62 ′ convert electrical signals into mechanical energy, resulting in vibratory motion of penetrating member 10 . The vibrations produced by the vibration actuators 62, 62' are in short increments (such as displacements up to 1 millimeter) and at frequencies (such as about 125-175 Hz) that reduce the force required to puncture and slide through tissue. , thereby improving insertion control with less tissue deformation and trauma, ultimately yielding higher vessel penetration/access success rates.

The vibratory motion produced by the vibratory actuators 62, 62' produces waves that may be sine waves, square waves, standing waves, sawtooth waves, or other types of waves in various embodiments. In the case of a Langevin actuator, the vibratory motion produced by the piezoelectric element 63 produces standing waves throughout the assembly, as shown in FIG. 16B. At a particular frequency, the standing wave consists continuously of zero displacement (nodes, or zero nodes) and maximum displacement (antinodes), so that the displacement occurring at any point along the vibration actuator 62 is Depends on where the displacement is measured. Therefore, the horns of Langevin transducers are typically designed with a length that presents the distal end of the horn at an antinode when the device is actuated. In this manner, the distal end of the horn undergoes a large vibrational displacement in longitudinal direction 61 with respect to the longitudinal axis of vibration actuator 62 . Conversely, the zero node is the perfect place to add port openings or slots to allow external devices to be connected.

In other embodiments, the vibration actuators 62, 62' may be voice coils for drive actuators rather than piezoelectric elements. A voice coil actuator (also called a "voice coil motor") produces a low frequency reciprocating motion. The voice coil has a bandwidth of about 10-60 Hz, depending on the applied AC voltage with a maximum displacement of 10 mm. In particular, when an alternating current is applied to the conductive coil, it results in a Lorentz force in the direction defined by the function of 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 held in place by the body. Magnetic members affixed to the drive tube cause the drive tube to transmit this motion to elongated members such as drive shaft 68 , which in turn transmits motion to penetrating member 10 . A first attachment point secures the distal end of the coil support tube to the body. A second attachment point secures the proximal end of the coil support tube to the body. The magnetic member may be made of a neodymium-iron-boron (NdFeB) composition. However, other compositions such as, but not limited to, samarium cobalt (SmCo), alnico (AlNiCoCuFe), strontium ferrite (SrFeO), or barium ferrite (BaFeO) can be used. A slightly weaker magnet may be more optimal in some embodiments, such as when the system is relatively small in physical size and the strong magnet is too strong.

Conductive coils may be made of different configurations, including but not limited to several layers formed by a single wire, several layers formed by wires of different circular or other geometric shapes. good too. In a first embodiment of the conductive coil, a first layer of conductive wire is formed with each complete turn forming the next turn of the previous one, and the wires descending along the initial longitudinal direction of the coil support tube. is radially wrapped around the coil support tube in a helical manner. After a predetermined number of turns, the wire continues to be wound in the same radial direction as the first layer by overlapping the first turn of the second layer of wire on top of the last turn of the first layer while at least Forming a second spiral of wiring with the same number of turns as the first layer, additional layers are formed on top of the first layer, each turn formed next to the previous turn, and the first layer is formed in the longitudinal direction opposite to the direction in which the was formed. The additional layers overlap 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, while at least as many turns of wire as the previous layer. Additional spirals may be added by forming additional spirals, each turn being formed next to the previous turn in a longitudinal direction opposite to the direction in which the previous layer was formed. In another voice coil embodiment, the positions of the magnetic member and the conductive coil are interchanged. In other words, the conductive coil is wrapped around and attached to 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 attachment site to create a Lorentz force in alternating directions that causes the conductive coil and elongated member to move relative to each other along the longitudinal axis of the device. In this embodiment, the conductive coil is in physical contact with the drive tube.

In another embodiment, the vibration actuator 62, 62' uses a dual coil mechanism in which the magnetic member of the voice coil is replaced with a second conductive coil. In other words, the second conductive coil is wrapped around and attached to 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 a second version, the inner coil conducts alternating current AC and the outer coil conducts direct current DC. In a 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 certain dynamic aspects of penetrating member 10 .

In yet another embodiment, vibration actuators 62, 62' are solenoid actuators. Similar to other voice coil embodiments that use coils, the basic principle of actuation by a solenoid actuator is caused by a time-varying magnetic field generated within a solenoid coil acting on a set of very strong permanent magnets. . The entire magnet and penetrating member assembly oscillates back and forth through a solenoid coil. The spring absorbs and releases energy on each cycle, amplifying the vibrations seen by penetrating member 10 . The resonance characteristics of the vibration actuator 62, 62' can be optimized by magnet selection, solenoid coil turns, shaft mass, and spring stiffness.

Although piezoelectric and voice coil mechanisms have been discussed for vibration actuators 62, 62', these are not the only approaches for actuating or vibrating penetrating member 10. Other approaches such as rotary motors can be used for the vibration actuators 62, 62'. In general, any type of motor that includes an actuator assembly, further including a mass coupled to piezoelectric material, a voice coil motor, a solenoid, or any other translational device, is within the spirit and scope of the present invention.

During use, feedback for tracking or confirming that the vibrating tip of the penetrating member 10 has reached the desired target point 29 location can be obtained in several forms. First, the vibrating tip of penetrating member 10 can be visualized on display 24 as its echoes are picked up by detector 20 during ongoing imaging by the insertion process. This can be done while viewing the image in a long-axis view or a short-axis view (as in FIG. 5C), or the user can switch between long-axis and short-axis views as desired to see the penetrating member 10. The progress of the tip can be traced. Second, the appearance of fluid, such as blood, within the penetrating member, also called "flashback," can be visually discerned, a change in resistance to a sub-circuit, or a change in the resonant frequency or phase of a vibrating needle tip. can be detected by a mechanism. Other methods of confirming that the tip of the penetrating member 10 has reached the preselected target point 29 can also be used.

After the tip of the penetrating member 10 has been successfully inserted into the target vessel and positioned at the desired target point 29, the rest of the procedure for successful central venous catheterization discussed above according to the Seldinger technique is accomplished. obtain. For example, in one embodiment, a guidewire 83 can be fed through the penetrating member 10 for insertion into the target vessel. Accordingly, the penetrating member 10 may be sized to accommodate a guidewire 83 having an inner diameter at least as large as the diameter of the guidewire 83 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 is in the range of 0.035-0.024 inches. could be. Of course, other sizes and gauges are also contemplated herein. Guidewire 83 may extend 1-3 cm beyond the tip of penetrating member 10, although shorter and longer distances for guidewire insertion are also contemplated. For example, the guidewire 83 may be fed through the interior 72 volume or space of the offset coupler 70 having an opening aligned with the hub 71 and thus the penetrating member 10, as seen in FIG. 16B. In other embodiments, guidewire 83 may be fed through lumen 76 of side port 75 of housing 73 of vibrator 60', such as neck 74 in front of hub 71, as in FIGS. Housing 73, neck 74, side port 75, and hub 71 may all be integrally formed together, or all may be luer connections or other suitable selectively removable connection mechanisms or any of these. They may be separate components selectively attachable to each other using combinations and the like. For example, in some embodiments, side port 75 is integrally formed with a neck 74 attachable to housing 73 at one end and hub 71 at an opposite end, as shown in FIG. 21B. Thus, neck 74 and side port 75 may be Y-adapters. In other embodiments, side port 75 may be mounted separately from housing 73 or neck 74 . In still other embodiments, neck 74 , side port 75 and hub 71 can be integrally formed and connected to housing 73 .

Once the guidewire 83 has been inserted through the penetrating member 10 and positioned within the target vessel, if desired, the penetrating member 10 is then pulled out of the vessel, such as by an extension actuator 52 moving in the opposite direction along the linear direction 51 . It can be retracted, leaving the guidewire 83 in place. The space can also be expanded by inserting and withdrawing dilators as needed. A catheter can then be inserted over the guidewire and the guidewire withdrawn from the vessel, leaving the catheter in place.

Vertical actuator 32 , angular actuator 42 , extension actuator 52 and vibration actuator 62 are incorporated into insertion device 100 . Accordingly, in at least one embodiment, the penetrating member 10 can be selectively removed from the insertion device 100, such as by attaching and detaching at the hub 71, so that a sterile penetrating member 10 can be used with each new patient or use. can do. Thus, the penetrating member 10 can be disposable and all the rest of the insertion device 100, including the detector 20, processor 22, and various actuators 32, 42, 52, 62 remain intact and reusable. be.

In at least one embodiment, at least a portion, but preferably the entire insertion device 100 up to and including hub 71 is reusable and can be contained in a sterile bag to maintain sterility. In some embodiments, the sterile bag can be cleaned with alcohol, bleach, or the like to avoid the need for the reusable insertion device 100 to undergo complete sterility precautions between each use. Or can be wiped off between uses. In other embodiments, hub 71 may be removable from offset coupler 70 or housing 73 for sterilization during use or disposal. In still other embodiments, the offset coupler 70 or housing 70 may be removable from the rest of the device 100, 100'' for sterilization during use or disposal. It is contemplated that throughout various embodiments, the reusable portion of the insertion device 100, 100'' can be placed in a sterile bag or similar structure to maintain sterility between uses.

In at least one embodiment, as shown in FIGS. 17-19B, the insertion device 100' can include a guidewire adjustment 80 for inserting a guidewire 83 as directed by the processor 22. The guidewire actuator 82 is in electrical communication with the processor 22 and receives operational data from the processor 22 to direct actuation and operational parameters based on actuator type, guidewire position, and the like. For example, in at least one embodiment shown in FIGS. 18A and 18B, the guidewire actuator 82 is a rotary motor that can have at least one, and possibly two, elongated members 85 extending from the guidewire actuator 82. be. Gear 84 of guidewire actuator 82 rotates at least one of elongated members 85 . In some embodiments, only one elongated member 85 is active and primarily engaged by gear 84 for turning or rotating. Another elongated member 85 is also present and may be paired with the first active elongated member, but may be passive such that it is not rotated by the guidewire actuator 82 . Thus, the passive elongated members 85 can only be rotated by movement in response to the movement of the paired active elongated members 85 , for example, by the interfitting of the teeth on the adjustment gear 84 between the elongated members 85 .

Opposite guidewire actuator 82 , elongate member 85 includes friction member 86 . In at least one embodiment, each elongated member 85 includes a friction member 86 that can be at a distal end of elongated member 85 . In other embodiments, only primary elongated member 85 includes friction members 86 , but preferably both active and passive elongated members 85 include 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 frictional engagement to move the guidewire 83 as it rotates. In some embodiments, as shown in FIGS. 18A and 18B, the guidewire 83 can be attached to and enclosed in a guidewire housing 89 to keep the guidewire 83 sterile when not in use. . In some embodiments, the guidewire 83 is held as a spool 88 within the housing 89 so that it can be stored compactly and easily rewound as needed. In other embodiments, the guidewire 83 can extend from the insertion device 100' and can be fed through the device 100' as needed. When guidewire actuator 82 rotates elongated member 85, whether wound on a spool or not, friction member 86 engages guidewire 83 and rotates to move guidewire 83 in the direction of rotation. Advance or retract the guidewire accordingly.

Guidewire 83 travels through guidewire channel 87 within guidewire housing 89 . Guidewire channel 87 is aligned and in fluid communication with interior 72 of offset coupler 70 such that guidewire 83 passes through channel 87 and through interior 72 of offset coupler 70 , hub 71 , and penetrating member 10 . It is designed to move forward. A guidewire 83 may be advanced past the distal end of the penetrating member 10 as previously described. Guide wire 83 may be retracted via the same route and mechanism as insertion device 100', but rotate elongate member 85 and friction member 86 in opposite directions.

The guide wire 83 must also be sterilized before use. Thus, in some embodiments, such as shown in FIGS. 19A and 19B, whatever the guidewire 83 contacts can be selectively removable and disposable, such as for one-time use. can. For example, a guidewire housing 89 containing spool 88, along with guidewire channel 87, offset coupler 70, hub 71, and penetrating member 10, can be used for detector 20, processor 22, and actuators 32, 42, 52, 62, and 82. All may be separable from the rest of the insertion device 100' so that all remains sterile and reusable. This is one advantage of having an offset alignment of penetrating member 10 from vibration actuator 62 . In other embodiments, only the guidewire 83 and penetrating member 10 can be removed and disposable, and the guidewire channel 87, offset coupler 70, and hub 71 can be sterilized between uses.

In yet another embodiment, as shown in FIG. 20C, guidewire 83 passes through vibration actuator 62 . In such embodiments, vibration actuator 62 and drive shaft 68 may have aligned lumens extending therethrough that function as guidewire channel 87 . A guidewire 83 can be advanced and retracted through these lumens.
Additional Embodiments FIGS. 23-28 illustrate additional embodiments of an automatic insertion device 300 and method 400 of using the same. These embodiments are used to automatically insert a penetrating member 310 such as a needle or catheter into a body cavity such as a blood vessel to access blood and fluids and place guidewires, dilators, catheters such as CVCs, and the like. It is a handheld device that can

As shown in Figure 23, the insertion device 300 includes a detector 326 for visualizing the subcutaneous target site. As with the previous embodiment, the detector 326 may be an ultrasound probe capable of using ultrasound to produce an image of the target site, although other types of image detectors are also contemplated. Detector 326 is in electrical communication with controller 319 and provides image data acquired by detector 326 to controller 319 . This imaging data may be relayed to a display for viewing by a physician or user of device 300 . Arm 325 couples detector 326 to the rest of device 300 . Attached to arm 325 is a handle 321 that can be grasped by an operator in use to manipulate device 300 to align detector 326 until a suitable target site is identified. As used herein, the terms "practitioner," "operator," "user," and other similar terms are used interchangeably to refer to the person who uses the device to control insertion of the penetrating member. can be

The controller 319 receives the imaging data from the detector 326 and converts the automatically calculated imaging data 323a into X and Y representing depth indices of the target site determined from the image data, as shown in FIGS. It further includes a processor 322 that can further process the imaging data, such as transforming it into target information, such as a coordinate solution, corresponding to the coordinates of the specified target site in three-dimensional space. Processor 322 may be a microprocessor or as described above. Control unit 319 also includes memory 219, shown in FIG. 26, in which imaging data and target information from detector 326 may be stored. Processor 322 further includes functionality for calculating an insertion angle for penetrating member 310 to enter tissue based on depth and other three-dimensional target information. In some embodiments, processor 322 includes a manual adjustment 323b option that allows a user to manually adjust the angle of positioner 320 to optimize the entry angle of penetrating member 310 .

Detector 326 remains adjacent to the skin surface during use of device 300 . Corresponding imaging data, including depth telemetry and X and Y target coordinates of the target site provided by detector 326, may change during the insertion process based on deformation or movement of the underlying tissue. Accordingly, imaging data is collected repeatedly by detector 326 at regular intervals, such as every 20 milliseconds in at least one embodiment. Each iteration of image data is provided to processor 322, which uses autocalculation 323a to recalculate and update target information for each iteration packet of image data received such that penetrating member 310 has been selected and stored. Proceed to target and ensure you stay on course.

As shown in FIG. 24, device 300 can include a positioning device 320 to which controls 319 can be attached. Positioning device 320 may also carry, house, and otherwise include vibrating assembly 360 and tensioning assembly 350, as discussed in more detail below. Penetrating member 310 is attached to the distal end of vibrating assembly 360 and is moved along insertion axis 311 defined by the targeting information for insertion into tissue by movement of tensioning assembly 350 . Positioning device 320 may be a platform or housing that encloses the components. In some embodiments, processor 322 further provides instructions to positioning device 320 in which vibrating assembly 360 and tensioning assembly 350 are positioned to move, for example, by rotation, of penetrating member 310 according to the target information described above. Angle can be adjusted.

Positioning device 320 also includes at least one probe, shown schematically in FIG. 27, preferably disposed on the outer and/or distal surface of positioning device 320 for detecting contact between positioning device 320 and a tissue surface. A surface proximity sensor 325 may be included. Such detection may indicate that the penetrating member 310 is not long enough to reach the selected target site and that another penetrating member 310 may be required, or that the positioning device 320 is on the tissue surface. Target information calculated based on the image data may be updated to indicate that the insertion angle should be changed to avoid contacting the . Accordingly, the processor 322 can receive contact information from the surface proximity sensor 325 indicating that contact has occurred between the positioning device 320 and the tissue surface. If such contact information is received, processor 322 can recalculate target information to avoid further contact. In the absence of contact information from the surface proximity sensor 325, the processor 322 can verify the adequacy of the target information, whether original target information or updated based on repeat imaging data.

Controller 319, specifically processor 322, is in electronic communication with vibrating assembly 360 and tensioning assembly 350, which are described in more detail below, and provides operating instructions based on target information and updated target information. Instructions can be provided, such as by transmission to vibrating assembly 360 and tensioning assembly 350 .

Apparatus 300 includes a vibrating assembly 360, shown in FIGS. 23 and 24, configured to generate vibration in longitudinal direction 61, as described above for previous embodiments. It is connected to the penetrating member 310 either directly or via a hub 371 as in FIG. Vibration assembly 360 includes a vibration actuator 362, such as a motor, that produces vibrations or oscillations when actuated. As used herein, the terms "vibration" and "oscillation" can be used interchangeably. Vibration actuator 362 may be any suitable motor such as, but not limited to, a voice coil motor (VCM), a piezoelectric motor with at least one piezo element, and a DC motor. Vibration actuator 362 can generate vibrations at a rate of 50 to 50,000 vibrations per second, depending on the vibration actuator type, frequency and/or input power. In at least one embodiment, the vibration rate may preferably be up to about 150 vibrations per second. The vibrations generated can vibrate the penetrating member 310 with an amplitude of about 5 μm to 1 mm, preferably 0.5 mm in at least one embodiment.

Vibration actuator 362 is in electrical communication with controller 319 , specifically processor 322 , and receives operating instructions from controller 319 . For example, device 300 may include vibration power switch 368 shown in FIG. 25, which may be an on-off switch in communication with controller 319. When activated or switched on, the controller 319 sends a signal to the vibration actuator 362 to turn it on and begin to generate the vibrations specified by the controller 319 . Vibration can be stopped by turning off the vibration power switch 368 . It can also be in direct electrical communication with the vibration actuator 362 in other embodiments, and in some embodiments is a potentiometer or otherwise turns the vibration actuator 362 along a continuum rather than on or off. It may have the ability to regulate the power supplied.

Referring to FIG. 27, which shows an electrical flow diagram of apparatus 300, vibration assembly 360 includes controller 319, processor 322, vibration control mode 322c (an optional subcomponent of processor 322) and/or tension assembly 350, described below. Vibration Control 372, which is an electrical module that determines the relative power level at which vibration actuator 362 should operate in response to signals received from. The output level of vibration actuator 362 is governed by the voltage applied to the actuator and/or the drive signal frequency. Instructions are sent from the control unit 319, the processor 322, or the vibration control mode 322c to the vibration control 372. The vibration control 372 relays the operation instructions to the vibration driver 367, and the vibration driver 367 sends signals such as voltage to the vibration actuator 367. to initiate and/or continue operation of vibration actuator 367 . Vibration actuator 362 may include sensors that detect the amplitude, power consumption, and load experienced by penetrating member 310 during insertion. This information is relayed to expansion assembly 350 either directly or indirectly via controller 319 or processor 322, as described in more detail below.

A vibrational load sensor 374 may be included to detect the load on the penetrating member 310 and to detect the attenuation of the vibration experienced by the penetrating member 310 during insertion. The vibration actuator 362 operates at a frequency that shifts as the coupled vibration penetrating member 310 engages tissue. This is because the additional elasticity of living tissue increases the stiffness of the combined system (vibration actuator 362 and tissue). As the vibration penetrating member 310 engages tissue, the tissue dampens the amplitude and effectiveness of the vibration. The frequency/voltage of the drive signal to vibration actuator 362 must be varied to limit the amplitude of vibration and damping of the effect. Changing the frequency/voltage of the drive signal requires providing additional power to the vibration actuator 362 to limit amplitude damping. The amount of power (such as Watts) supplied to vibration actuator 362 is referred to as vibration power consumption. Vibration power consumption can also be detected via a voltage sensing element in vibration assembly 360 according to the following equation:
Power=Irms*Vrms
where Irms is current and Vrms is voltage. Vibration power consumption can be determined from the current and voltage measured at vibration actuator 362 . Damping the vibration amplitude therefore requires additional power consumption to counteract the damping.

"Load" is the axial force applied to the penetrating member 310m Newtons (N) and can be detected by the vibratory load sensor 374 that measures the force. Vibrational load sensor 374 may be a circuit or other suitable mechanism. In one embodiment, vibration load sensor 374 may be a shunt resistor and amplifier. In other embodiments, the load and damping of the penetrating member 310 can be mechanically sensed using an LVDT sensor. Vibration actuator 362 itself also functions as a vibration load sensor that receives feedback of forces applied to penetrating member 310 via coils or magnets within vibration actuator 362 and can also receive such forces. Additionally, the power consumed by the tension actuator when the penetrating needle encounters harder tissue can be adjusted based on the "load" also defined herein. Alternatively, the phase relationship between the load current and voltage of vibration actuator 362 can be monitored, and the damping or load effect on penetrating member 310 can be inferred from changes in this phase relationship.

The penetrating member 310 damping and vibration actuator 362 load current feedback are related to the operating parameters of the vibration actuator 362 and are sent to the vibration power and load control 376 module which determines the load and damping effects experienced by the penetrating member 310 . may be Vibration load control 376 may send signals to vibration motor control 372, processor 322 and/or vibration mode control 322c to adjust vibration speed based on feedback from penetrating member 310. FIG. This information may also be sent to stretching assembly 350 directly or via controller 319 and/or processor 322 to adjust the rate of insertion based on the vibratory load experienced by penetrating member 310 under vibration.

Apparatus 300 also includes a tensioning assembly 350 as shown throughout the figures. As described above, the tensioning assembly 350 is configured to move the penetrating member 310 in the linear direction 51 for insertion and retraction of the penetrating member 310 . Extension assembly 350 includes extension actuator 352, which is a motor such as, but not limited to, a linear or translational motor, and may be operated by any suitable mechanism. The extension shaft 353 is mechanically coupled to the extension actuator 352 at one location, such as via an extension mount 354, as shown in FIG. 362 , or any other component that is movable with the penetrating member 310 . The extension shaft 353 is preferably rigid and can be extended by a telescopic motion in at least one embodiment. Extension assembly 350 is in electronic communication with controller 319 and/or processor 322 to provide and receive operating instructions. For example, the stretcher assembly 350 can also include a stretcher power switch 357 that can be mounted anywhere on the device 300, such as the controls 319, the exterior surface of the positioning device 320, or the handle 321 as shown in FIG. A stretcher power switch 357 can be used to turn the stretcher assembly 350 on or off. In at least one embodiment, stretcher power switch 357 closes the circuit to provide operating power to stretch actuator 352 to move stretch shaft 353 in linear direction 351 . The direction of movement can be controlled by a directional switch 356 shown in FIG. 25, which can also be placed anywhere on the device 300 . Directional switch 356 is a switch that can be toggled between a forward direction for advancing elongated shaft 353 for insertion of penetrating member 310 and a reverse direction for retracting elongated shaft 353 and removing penetrating member 310 . obtain. The ready or retracted position of extension assembly 350 is shown in FIG. 23 with extension shaft 353 fully retracted, and the inserted or deployed position is shown in FIG. 24 with extension shaft 353 fully extended in linear direction 51 . shown in

Extension actuator 352 is configured to operate at different speeds to insert penetrating member 310 at different speeds depending on the vibrational loads and/or damping experienced by penetrating member 310 during insertion. For example, in at least one embodiment, extension actuator 352 operates at a first operating speed in a first mode, operates at a second operating speed in a second mode, and operates at a third operating speed in a third mode. Operates at operating speed. Any number of modes are possible, each with its own speed of operation. 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 has a first velocity 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. It is configured to operate at one operating speed. Accordingly, various modes can be used to adjust the insertion speed depending on what the penetrating member 310 encounters during insertion. For example, if the penetrating member 310 experiences increased load or vibration damping, a slower insertion speed can be used, and if the penetrating member 310 experiences less load or vibration damping, a faster insertion speed can be used. can do. As described below, any of the operating modes can be set as the default mode in which the extension actuator 352 operates by default, unless otherwise determined. For example, the extension actuator 352 can, in at least one embodiment, use a first mode with an operating speed of 2.0 cm/sec to reduce the insertion speed and reduce the vibration load experienced during insertion. increase can be compensated.

Power consumption may also be defined by the power required by the extension motor to sustain advancement as different tissues are penetrated by the attached penetrating member 310 . This power consumption is sometimes called decompression power consumption. The extension actuator 352 itself may be a sensor of how much resistance the penetrating member 310 experiences during insertion, such as may occur when denser tissue is encountered. increase the power consumption of the extension to continue to operate at a particular insertion speed. Feedback of the extension power consumption and the current insertion rate therefore directs controller 319 and/or processor 322 to adjust vibration based on the extension power load experienced by penetrating member 310 experienced by extension actuator 352 during insertion. can be transmitted to the vibrating assembly 360, either directly or indirectly via.

Tension assembly 350 also includes electrical circuitry for transmitting and receiving signals and information with controller 319 , processor 322 , and vibration assembly 360 . For example, as shown in FIG. 27, the extension assembly 350 provides controls such as to activate the extension actuator 352 when the stretcher power switch 357 is activated, or to indicate which operating mode and speed to use. An extension motor control 358 may be included that receives operating signals from 319 . The prescribed parameters and corresponding velocities for each operating mode can be stored in memory 318 within controller 319 or in memory within extension motor control 358 or extension assembly 350 . The extension motor control 358 sends motion commands to the extension driver 355 , which sends signals, such as voltages, to the extension actuator 352 to actuate the extension actuator 352 and move the penetrating member 310 in the direction indicated by the directional switch 356 . move to

Extension motor control 358 may also receive signals from vibration assembly 360 , such as from vibration load control 376 regarding the load and damping experienced by penetrating member 310 . This may be in the form of changes in vibration amplitude and/or motor power consumption experienced by vibration actuator 362 coupled to penetrating member 310 . Preferably, these signals and/or adjustments occur repetitively at regular intervals throughout the insertion process, for example every 20 milliseconds, although other time intervals shorter than the total time of insertion are contemplated. .

The velocity of tension actuator 352 increases or decreases in response to changes in vibration amplitude damping and/or power consumption of vibration actuator 362 resulting from loading of penetrating member 310 as penetrating member 310 progresses through different tissue types. can be adjusted by the extension motor control 358. For example, when the penetrating member 310 encounters stiffer, harder, or more difficult tissue to penetrate, such as a tendon, the vibrations imparted to the penetrating member 310 are dampened and the penetrating member 310 is , the power consumption of vibration actuator 362 changes, and/or a larger drive signal (eg, voltage amplitude) is required to maintain vibration displacement. When such increased load is signaled to the extension assembly 350, the extension actuator 352 slows the insertion speed to accommodate the increased load. For example, adjusting from the first mode to the second mode for slower speeds, or from the second mode to the third mode for even slower speeds, depending on which mode the extension actuator 352 is currently operating in. can do. Conversely, if the load experienced by the penetrating member 310 decreases, such as indicating that soft tissue is being encountered, a signal of decreased oscillatory load is sent to the stretcher 352, causing the stretch actuator 352 to operate at a higher velocity. For this purpose, the operating speed is adjusted to a higher operating speed, such as moving from the third mode to the second mode or from the second mode to the first mode. Upon reaching a change that reaches a predetermined threshold, the operating mode of extension actuator 352 is changed to the next closest mode, depending on whether the change reflects an increase or decrease in load.

The present invention also includes a method 400 of using the apparatus 300 described above, shown in FIG. The method 400 initially includes determining a target angle and trajectory at 410 . This involves placing the detector 326 on the skin or other surface of tissue and using the automatic calculations 323a of the processor 322 to determine the appropriate insertion angle and distance from the current position of the penetrating member 310 to the selected target. can be achieved by determining Certain embodiments may include 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 memory 318 of controller 319 .

The method 400 continues with providing operating instructions for the vibration parameters to the vibrating assembly 360 and insertion speed and distance to the tensioning assembly 350 as at 415 . For vibrating assembly 360, these can include amplitude, voltage, frequency of vibration, and other parameters as described above. For the extension assembly 350, the insertion speed operating parameter may be the speed corresponding to the default mode. Range corresponds to target information and trajectory determined based on imaging information from detector 326 , as may be determined by controller 319 and/or processor 322 . Operating instructions may be provided to each assembly 350 , 360 when the device 300 is turned on, or may be stored in circuitry or memory of the vibrating assembly 360 or memory of the controller 319 .

The method 400 continues with activating the positioning device 320 as at 420 . This may include powering on the positioning device 320 , the vibration actuator 362 and the extension actuator 352 . This can occur in stages, one at a time, or simultaneously. In at least one embodiment, vibration actuator 362 is activated before extension actuator 352 so that penetrating member 310 vibrates longitudinally prior to advancement for insertion. When activated, each of the actuators 362 , 352 can be stored in respective circuits, such as vibration control 372 and extension motor control 358 , and stored data provided from controller 319 and/or processor 322 of device 300 . It operates according to initial or default operating parameters, which may be operational instructions. In at least one embodiment, extension actuator 352 can begin to operate in a first mode and vibration actuator 362 can operate in a first vibration mode.

The method 400 measures the vibration power consumption and/or vibration displacement provided by the vibration actuator 362 and the extension of the extension actuator 352, such as continuously or repeatedly detecting respective workloads throughout the insertion process, as at 430. Including monitoring power consumption and/or load. Each iteration of monitoring can be performed at any time interval, such as, but not limited to, 20 milliseconds, depending on the desired sensitivity of the system. This can be accomplished by the vibrational load sensor 374 and the extension actuator 352 or other inserted load sensors described above. The method then proceeds at 440 with comparing the detected vibration load to a predetermined vibration value and comparing the detected insertion load to a predetermined extension value; if and when a deviation is detected adjusting the insertion rate of the extension actuator 352 and/or if and when a sufficient deviation from the extension workload of the extension actuator 350 is detected; and adjusting the vibration of the vibration actuator 362 . These adjustments can be made by providing signals to the appropriate vibrating assembly 360 and/or tensioning assembly 350 to make corresponding adjustments, which are sensitive to changes in the sensed workload and the It can depend on whether the value is exceeded positively or negatively. For example, the method 400 can include decreasing the insertion speed when the vibration load on the vibration actuator 362 increases by a predetermined vibration threshold, as at 442 . For example, the predetermined vibration value may be a 30% amplitude and/or 50% increase in power consumption compared to the initial starting value or the load samples from the most recent iteration sampling. Similarly, method 400 can include decreasing vibration power, amplitude, or other operating parameter, as at 443, when the insertion load of extension actuator 352 is increased by a predetermined extension value. In some embodiments, the predetermined expansion value is 0.25 times, 0.5 times, 1.0 times, 1.5 times the power for the inserted load sample from the initial starting power or the most recent iteration sampling, Or it can be a 2.0 fold increase. The predetermined vibration and extension values may differ in other embodiments, including the initial starting workload and velocity, the tissue to be penetrated, the properties and types of vibration actuator 362 and extension actuator 352 used, the It may depend on many factors, including but not limited to the amount of initial power applied, and other factors. This reduction in insertion speed is used to adjust the insertion speed, e.g. from a first mode to a second mode, or from a second mode to a third mode, each with a reduced level of insertion speed. , from operation of the extension actuator 352 to transition from one operational mode to the next available operational mode. It may also correspond to transitioning the vibration actuator 362 from one vibration mode to another vibration mode. The method 400 contemplates changing operating parameters of both, only one, or none of the vibration actuator 362 and the extension actuator 352 depending on the load on the opposing actuator.

Conversely, the method 400 includes increasing the insertion speed when the vibration load on the vibration actuator 362 decreases by a predetermined vibration value, as at 444, or increasing the insertion load on the extension actuator 352, as at 445. increasing the vibration of the vibration actuator 362 upon decreasing by a predetermined stretch value. The predetermined vibration 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. Therefore, the change is 30% amplitude and/or 50% power consumption deviation compared to the previous vibration load sample of the vibration actuator 362 or 0.00% compared to the previous insertion load of the extension actuator 352 . It can also be described as a deviation from a given value, such as a deviation of insertion load by a factor of 5. However, in other embodiments, the predetermined vibration and extension values for increasing insertion speed or vibration may be different than the values for decreasing insertion speed or vibration. Again, an increase in the insertion velocity or vibration is followed by movement of the extension actuator 352 from the third mode to the second mode, or from the second mode to the third mode, etc., where the insertion velocity is increased, respectively, and then It can be caused by a transition to an available operating mode. Additionally, 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 be shortened, feedback may be more frequent as the vibration load increases, then longer, and feedback less frequent as the vibration load decreases, or vice versa. In at least one embodiment, the sampling rate or sampling interval may remain constant throughout the insertion process.

The step of monitoring the vibratory workload as at 430 continues throughout the insertion process, preferably between the operating modes of the extension actuator 352 and the vibration actuator 362, and other actuators as needed. Based on the load, adjustments are made to incrementally increase or decrease the insertion speed or vibration throughout the insertion process.

Method 400 ends by stopping the insertion as at 450 . This may occur automatically in several ways, for example, when a preselected target is reached according to a trajectory calculated or determined based on imaging information. Reaching the target site may be confirmed by the presence of an adequate amount of blood or fluid escaping from the target, indicating that the distal tip of penetrating member 310 is located within the interior volume of the blood vessel. Stopping insertion, such as 450, can also occur when contact between the device 300 and the tissue surface is detected, such as by the surface proximity sensor 325 described above. In this case, vibration actuator 362 can simultaneously stop vibrating and extension actuator 352 can reverse to retract penetrating member 310 . The positioning device 320 also informs the operator that the length of the penetrating member 310 is insufficient for the intended target depth, such as by light, sound, or other operator-observable indicator. can be done.

When insertion of penetrating member 310 stops, active operation of vibration actuator 362 and extension actuator 352 is discontinued by processor 322 . Upon successful introduction of penetrating member 310 to the intended target, such as by the appearance of blood or other bodily fluids suitable for the penetrated tissue, the interior of the target site extracts or extracts material through penetrating member 310 . It can be access to insert. For example, blood can be drawn, drugs or solutions can be applied, and/or a flexible guidewire can be inserted through the hollow interior of penetrating member 310 . Penetrating member 310 still in the target site may be disconnected from the device, such as by detaching 460 from vibrating assembly 360 at hub 371 . Hub 371 can then be used as a connection point for syringes or vials for blood collection or drug/solution delivery, or as a connection point for an IV system. A guidewire can be inserted through the penetrating member 310 before or after it is disconnected from the rest of the insertion device 300 . If a guidewire is inserted through penetrating member 310 while it is still connected to device 300, positioning device 320 with penetrating member 310 attached and the remainder of device 300 may be displaced by the operator. is gently withdrawn from the tissue through the flexible guidewire until the operator sees evidence of a flexible guidewire extending from the skin surface that can be safely disengaged from interaction with the flexible guidewire. may

Since many modifications, changes and variations in detail may be made to the described preferred embodiments, it is intended that all matter shown in the foregoing description and accompanying drawings shall be interpreted by way of illustration and not in a limiting sense. intended to be interpreted. Accordingly, the scope of the invention should be determined by the appended claims and their legal equivalents. The present invention has been described above.

Claims (20)

An apparatus for inserting a penetrating member into tissue along an insertion axis comprising:
a detector;
a controller having a processor and a memory;
A vibration assembly connected to the penetrating member, the vibration assembly having a vibration actuator in electrical communication with at least one of the control portion and the tensioning assembly, the vibration actuator responsive to at least an insertion load. generating axial vibrations along the insertion axis in accordance with a defined operational vibration command in partial response; transmitting the axial vibrations to the penetrating member; sensing a vibrational load on the vibration actuator; a vibrating assembly configured to send a signal indicative of the vibratory load to one of the controller and the tensioning assembly;
The tensioning assembly is connected to the penetrating member and in electrical communication with at least one of the controller and the vibration assembly, the tensioning assembly having a defined motion insertion at least partially responsive to the vibrational load. a tension actuator configured to axially move the penetrating member along the insertion axis at an insertion velocity in accordance with instructions; further configured to send a signal indicative of load to one of the controller and the vibrating assembly;
Device. 2. The apparatus of claim 1, wherein the vibration load is at least one of amplitude and power consumption of the vibration actuator, and wherein the insertion load is power consumption of the extension actuator. 2. The device of claim 1, wherein the penetrating member is selectively removable from the device. 2. The apparatus of claim 1, wherein the extension assembly includes an extension shaft movable relative to the apparatus by the extension actuator, the extension shaft connecting to the vibratory assembly. 2. The apparatus of claim 1, wherein the vibration actuator is one of a voice coil motor, a piezoelectric motor, and a DC motor. the vibration assembly includes a vibration load sensor in electrical communication with the vibration actuator and configured to detect at least one of an electrical and mechanical representation of the load on the vibration actuator; 2. The apparatus of claim 1, wherein the vibration load sensor is one of (a) a shunt resistor and amplifier, (b) an LVDT sensor, and (c) the vibration actuator. The vibration assembly is in electrical communication with the vibration actuator to (a) determine the vibration load from the at least one of electrical and mechanical indications from the vibration load sensor; and (b). 7. The vibratory load control of claim 6, comprising a vibratory load control configured to at least one of: send the signal indicative of the vibratory load to one of the controller and the extension assembly. Device. The extension assembly includes an extension control in electrical communication with at least one of the controller, the processor, and the vibration assembly, the extension control (a) determining the insertion load of the extension actuator; 2. The apparatus of claim 1, configured to b) transmit said signal indicative of said insertion load to one of said controller, said processor, and said extension assembly. At least one of the controller and the processor (a) receives the signal indicative of the vibration load and the insertion load; (b) compares the signal indicative of the vibration load to the predetermined vibration value; (c) providing a motion insertion command to the extension actuator to alter the insertion speed when the signal indicative of the vibration load deviates from the predetermined vibration value; compared to an insertion value and providing an operating vibration command to the vibration actuator to modify the vibration when the signal indicative of the insertion load deviates from the predetermined insertion value. Item 1. The device according to item 1. Further comprising a positioning device supporting the vibrating assembly and the tensioning assembly, the device further comprising a surface proximity sensor located external to the positioning device and in electrical communication with the controller, the surface proximity sensor comprising: , configured to detect contact between the positioning device and a tissue surface and provide a signal of detected contact to the controller. A method of automatically inserting a penetrating member into tissue comprising:
providing an apparatus having a detector, a vibration actuator, and a tension actuator;
determining a target site in tissue into which the penetrating member will be inserted;
acquiring imaging data of the target site with the detector;
determining target information of at least an insertion distance for the penetrating member to reach a selected target site based on the imaging data;
providing vibration parameter operating instructions for the vibration actuator and insertion speed and insertion distance operating instructions for the extension actuator based on the target information;
activating the vibration actuator to initiate vibration and activating the tension actuator to initiate insertion of the penetrating member into the tissue in accordance with the motion command;
detecting a vibration load of the vibration actuator and an insertion load of the extension actuator;
comparing the detected vibration load to a predetermined vibration value and comparing the detected insertion load to a predetermined extension value;
adjusting the insertion speed of the extension actuator if the detected vibration load deviates from the predetermined vibration value; and adjusting the vibration of the vibration actuator if the detected insertion load deviates from the predetermined extension value. and
A method, including The step of adjusting the insertion speed includes (a) decreasing the insertion speed if the detected vibration load on the vibration actuator increases beyond the predetermined vibration value; and (b) the vibration. 12. The method of claim 11, further comprising one of: increasing the insertion speed when the detected vibration load on the actuator decreases below the predetermined vibration value. 13. The method of claim 12, wherein the predetermined vibration value is at least one of a percentage amount of amplitude and a percentage amount of power consumption of the vibration actuator. 14. The method of claim 13, wherein the predetermined vibration value is at least one of 30% amplitude and 50% power consumption. The step of adjusting the vibration comprises: (a) increasing any of the output, amplitude, and frequency of the vibration actuator when the detected insertion load of the extension actuator decreases below the predetermined extension value; (b) if the detected insertion load of the extension actuator increases below the predetermined extension value, reducing any of the output, amplitude, and frequency of the vibration actuator; 12. The method of claim 11, further comprising one of: 16. The method of claim 15, wherein the predetermined extension value is one of 0.25, 0.5, 1.0, 1.5, and 2.0 times the extension actuator. Method. monitoring the vibration load of the vibration actuator and the insertion load of the extension actuator by repeated detection, wherein the detected vibration load and insertion load are combined with the predetermined vibration value and the predetermined extension value; 12. The method of claim 11, further comprising the step of comparing each to is performed for each iterative detection. either (a) moving a full predetermined distance to reach a selected target; or (b) detecting contact with a tissue surface by a component other than the penetrating member. 12. The method of claim 11, further comprising stopping insertion of the penetrating member when it occurs. 12. The method of claim 11, further comprising inserting a guidewire through the penetrating member once the target site is reached. 12. The method of claim 11, further comprising disconnecting the penetrating member from the positioning device.

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