Passage systems and methods

Abstract

Systems and methods for dialysis cannula insertion, including an apparatus including a structure configured for placement of a needle or cannula to provide vascular access, or a method involving the structure. In one method, a self-cannula insertion system for use in hemodialysis is provided.

Description

Technical Field

[0001] The present disclosure generally relates to a system and method for cannulating a vasculature or a graft. Background Art

[0002] There is a continuing need for an effective alternative for providing vascular access, and particularly for hemodialysis. Additionally, there is a need for an access system that is easy to use and effective for use in a clinic or at home.

[0003] Hemodialysis has become a routine way to treat patients with kidney disease. The hemodialysis procedure, commonly referred to as dialysis, involves filtering waste from the body's blood, thereby supporting or replacing the biological functions provided by healthy kidneys. Effective dialysis helps to balance the substances resident in the blood, including calcium, potassium, and sodium, and helps to control blood pressure.

[0004] Hemodialysis involves passing blood through a dialyzer, which acts as a filter to balance the blood components, much like an external kidney. In a hospital or clinic setting, medical staff are responsible for setting up the dialyzer and connecting the patient to it. This involves obtaining access and placing needles that connect or can connect to a cannula within the patient's vasculature, and connecting the tubing to and from the dialyzer.

[0005] Typically, hemodialysis treatments last about four hours and are performed three times a week, but some patients may require more frequent and longer treatments. In addition to this, the time spent traveling to the treatment center and waiting to be connected and disconnected from the dialyzer of course requires a significant commitment of time and effort from the patient.

[0006] It is precisely due to these limitations associated with dialysis performed in a treatment center, including cannulation, that more effective hemodialysis, including cannulation, has become an ideal alternative for treatment centers or at home. Therefore, it is desirable to make dialysis and the assessment of the insertion site and the cannulation itself more efficient and / or require less skill. Research has shown that performing home dialysis five to seven times a week has significantly better results in many respects, including extended lifespan and increased survival rates. When dialysis is performed at home, there is no need to travel to a dialysis center. Home dialysis also offers greater flexibility, as patients are able to choose convenient dialysis times and have a greater sense of control by being independent and performing the treatment themselves.

[0007] However, unless involved in home care, there are usually no medical professionals in the home environment to monitor treatment or answer immediate questions. Additionally, importantly, at treatment centers, healthcare professionals rarely are able to assist with or perform the cannulation techniques required to insert a needle into a patient's blood vessel in order to be able to connect the patient to a dialyzer. Cannulation is a skilled nursing task. Moreover, for many patients, self-cannulation can be a daunting task, and many patients may lack the necessary dexterity or skills to insert the needle repeatedly, effectively, and efficiently to access the vasculature through the insertion site. Since correct and repeatable cannulation is crucial for successful hemodialysis and for avoiding infections and other complications, currently unassisted home dialysis is not a practical alternative for a large number of patients.

[0008] Accordingly, there is a need for effective and efficient devices and methods for cannulation, and for reducing or shortening the time required for hemodialysis, and for performing hemodialysis in a treatment center or home environment using an easy-to-use system to help minimize trauma and infection. These methods should be associated with predictable outcomes and be relatively easy to employ.

[0009] This disclosure addresses the above and other needs. SUMMARY OF THE INVENTION

[0010] Briefly and generally speaking, this disclosure is directed to access systems and methods for a cannulation system that helps provide vascular access. These methods of the cannulation system are configured to define an acceptable access path that prevents the user or system from entering an unacceptable path or inserting beyond a defined endpoint, and are configured to define a narrow range of acceptable paths and a most desired path. In one aspect, the defined endpoint is within the wall of a defined target graft or blood vessel.

[0011] The cannulation system is configured for central or home dialysis and can be operated by a patient, a skilled healthcare provider, or an unskilled person. In one embodiment, the cannulation system includes a detection bed, an armature attached to the detection bed, and a needle holding clamp attached to the armature. The detection bed is provided with a structure for repeatably and consistently attaching a patient's body part to the detection bed and relative to the armature. The cannulation system is particularly suitable for patients who require multiple repeated cannulations. Since the cannulation sites and the paths to these sites are pre-planned and pre-determined, the system is set up to enable quick, repeatable arm / vessel placement and confirmation without the need to gather information about the patient or the cannulation site during each cannulation procedure.

[0012] In one embodiment, one or more fiducial points are implanted in a patient, and through a pre-scan process, the fiducial points are used to register the patient and map the precise location of the target vasculature, whether it is an artificial graft or a natural passage anatomical structure including a fistula or the blood vessels themselves. Additional scans are performed as needed (such as periodically) to confirm the position of the target vasculature or graft relative to the implanted fiducial points or other markers. In one approach, the additional scans can be performed as scheduled (such as every six months or longer). The pre-scan process can involve medical staff formulating strategies and plans for mapping the manner in which one or more needles are advanced into the target vasculature through an acceptable path. The strategy or plan can include a short segment of the acceptable path and the most desirable vascular access path. The plan can include mapping the path to a number of predetermined cannulation sights, which can then be accessed in turn via a rope ladder channel technique. The acceptable cannulation sights and paths can both be determined after the pre-scan process and before the patient undergoes dialysis. Thus, in one embodiment, the cannulation site and cannulation path do not require real-time calculation, but can all be determined before the patient places the arm on the detection bed.

[0013] In use, in one embodiment, the patient simply attaches their arm or other body part to the detection bed, and the cannulation system identifies the patient and knows the acceptable path for the needle to take to effect cannulation. The cannulation system guides the needle to move through the acceptable path, thus preventing the needle from entering an unacceptable path or inserting beyond a defined end point.

[0014] In one embodiment, the cannulation system is servo-controlled, where a servo motor is attached to each moving part of the support frame, and a sensor is associated with each servo motor, such that a patient or another person can grasp the needle or the needle holding fixture and move the needle through a path guided or constrained by the servo motor.

[0015] In another embodiment, the cannulation system is manually operated by a user, and the user sets each movable part of the cannulation system according to a predetermined plan. Here, the support frame of the cannulation system lacks a servo motor or sensor or other electronics.

[0016] In yet another embodiment, once the body part is attached to the detection bed and the patient is registered, the cannulation system autonomously operates to achieve vascular access.

[0017] In one embodiment, a cannulation system includes structures and functions for targeting blood vessels and positioning one or more needles within a target vasculature without the need for a skilled person. The one or more needles are held within a needle holding jig, and once the examination table has registered the patient, a support frame is used to advance the needle along a path calculated based on real-time fiducial points or anatomical data and / or pre-recorded anatomical data into the target vasculature or graft or fistula. In one aspect, the one or more needles are advanced into the patient's body and the target vasculature at a predetermined angle and depth. Notably, the system is effectively used to provide vascular access and assist in cannulation for the whole body, particularly including for radiocephalic fistulas, brachiocephalic fistulas, and venous transposition fistulas, and the scope can be from the forearm to the upper arm or other locations on the body.

[0018] In a preferred embodiment, the system is implemented as a cannulation system that includes an examination table equipped with or associated with a body part attachment structure, and a support frame including a needle holding jig attached to or associated with the examination table. The positioning technology is embedded in the examination table, and its relationship with the body part attachment structure and the support frame is fixed.

[0019] Once the patient's arm is stabilized on the bed, the position of fiducial points within the patient's arm or other body part is detected and connected via the system software. The position of the fiducial points is compared with a previously recorded 3-D data set, and then the position of the vascular access site can be virtually mapped onto the support frame, and the tip of the needle is predicted or directed to be positioned there. The needle holding structure is attached to the needle in a fixed and repeatable manner such that the position of the tip of the needle (once fixed into the needle holding structure) relative to all anatomical markers is known via the system software. Once the needle is locked into the needle holding structure, using the data provided by the software, the proposed orientation of each degree of freedom of the needle support structure can be known. In a manual manner, these settings can be communicated to the user via a display, and then the user sets each joint or moving part of the support frame. In a servo-motor-based manner, each degree of freedom of the support frame is guided or restricted by the servo motor to allow the needle to move along an ideal path through each degree of freedom.

[0020] In a preferred embodiment, the patient's arm is stabilized in the detection bed of the cannula insertion system, and the detection bed scans the fiducial points implanted in the arm to understand the accurate orientation of the arm within the cannula insertion system and relative to one or more components of the cannula insertion system. The position of the arm can be exactly the same as the normal or expected position, or the arm can be slightly rotated or deviated from the expectation. The system adjusts the previously calculated and known path to account for any slight differences in the arm position, whether these differences are translational, rotational, or a combination of both. The cannula insertion system makes this automatic or semi-automatic adjustment, or makes the adjustment manually under guidance. If the position of the arm is significantly different from the expectation, the system can warn the patient or the healthcare provider. In such a case, the system can calculate a partially new or completely new path and trajectory based on the new information.

[0021] During the pre-scanning, mapping, and planning process, one or more of MRI scanning, CT scanning, ultrasound scanning, infrared view, or 3-D photography are used to collect information about the patient's vascular morphology and anatomy. In one embodiment, information about the target anatomy and / or vasculature relative to the implanted fiducial points is collected and stored in the cannula insertion system memory. In a particular aspect, the cannula insertion system is implemented as a passive limiter array that fixes the travel range of each degree of freedom of the support frame, and in various ways, uses a combination of imaging data and information from real-time fiducial points corresponding to the vascular access target to determine information about the settings of each passive limiter and display it on the device.

[0022] In various embodiments, the system can also track the insertion site, size, position, and geometry, insertion date, flow rate, treatment frequency, and treatment length, and allow patient input to track and monitor complications or infections. In certain alternative embodiments, the system can suggest an insertion site based on a combination of historical data on the patient's previous use of the device to insert the cannula and the patient's anatomical imaging data, as well as in view of the patient input, to provide options for the patient or the healthcare provider regarding needle placement. In certain alternative embodiments, the system can also utilize population data from other systems in the system that have similar anatomical structures and vascular morphologies and have successfully inserted cannulas at a given site to further inform the system's suggestions. Additionally, in alternative embodiments, the system includes a remote interface or computer that allows the patient, the healthcare provider, or other connected health devices (e.g., via Bluetooth) to input patient health information, which includes heart rate, blood pressure, and blood flow, as well as the patient's diet, medication regimen, and exercise.

[0023] In an alternative embodiment, the system controller manages or provides an assessment of the fistula or graft prior to cannulation. If an obstruction is detected, the system will block the cannulation procedure and may alert the patient or healthcare provider so that further assessment and / or intervention can be performed. Various sensors and actuation mechanisms are provided to automate the assessment process or portions thereof. In some ways, the system is implemented as one or more sensors that identify tremors or vibrations, operate like a stethoscope to track bruits (i.e., the sound of the heartbeat or blood flow), or listen for flow to detect obstructions.

[0024] In one or more aspects, an access system includes one or more fiducial points or markers that assist in introducing a needle into a patient's skin relative to a vascular access site. In alternative embodiments, the fiducial points or markers can be one or more implants, tattoos, magnetic markers, radiopaque materials, or other features that occur naturally in the area near or at the intended vascular system access site.

[0025] In a preferred manner, the fiducial markers are configured to be implanted and attached to the radius and / or ulna of the forearm, or placed at one or more locations in bone or soft tissue near the vascular system access site. The vascular system access site fiducial points or markers can be co-registered with previously acquired infrared views, MRI, ultrasound, or CT scans to initially set patient data for subsequent cannulation.

[0026] In alternative embodiments, the system can be configured to re-adjust the trajectory and / or depth of the needle movement in the event that the patient moves before, during, or between cannulations. Additionally, the fiducial points or markers can alternatively or additionally be one or more RFID chips, electromagnetic, metal implants, radiopaque materials, or other features that occur naturally in the area near or at the intended vascular system access site.

[0027] In another alternative for inserting a needle into a vascular access site, a sensor package is provided that can both locate and assess a fistula or graft prior to cannulation. The sensor package can be attached to an automated mechanism that moves along the arm, or can be implemented in a sleeve or other structure that the patient can move along the insertion site. Information collected by the sensor package is fed into the system to assist in determining the desired cannulation location. Additionally, the sensor package can be configured to continue to assess the cannulation status and communicate it to the patient or healthcare professional.

[0028] In one or more alternative ways, the patient can move the components of the cannula insertion system and advance the needle themselves, taking into account their own sensations, pain, or comfort level, where the system ensures that the needle does not take the wrong path or is inserted deeper than a defined and desired endpoint. Additionally, in each or one or more alternative ways of the disclosed embodiments, the system can automatically position, aim, and advance the needle during the cannulation procedure. Further, in alternative embodiments and ways, the patient and the system work together in different degrees and various ways, such as where the patient has the system guide the needle into position but wants to push the needle into the vasculature, or where the patient moves the structure holding the needle and has the system push the needle into the vasculature when the system is ready or when the patient indicates they are ready and gives a signal that cannulation should proceed (such as by pressing a cannulation button).

[0029] In one embodiment, the cannula insertion system includes a sleeve or chamber that can be positioned on the patient's arm or into which the patient's arm is inserted. The sleeve is configured to lock onto the patient's arm and helps to fix the patient's arm relative to the examination table. In another way, the sleeve or chamber includes a molded insert, the profile of which can receive the patient's arm and position the patient's arm relative to the examination table, and the molded insert is created, for example, via 3D printing from a model of the patient's arm, such that the profile of the mold allows the arm to sit firmly and comfortably within the molded insert. The system can communicate with the examination table to adjust the position of its arm.

[0030] In various other alternative aspects, the cannula insertion system can include one or more invisible light, acoustic, pressure, or visual sensors for determining and tracking blood flow. In this way, the effectiveness of the cannulation and the patient's health status can be confirmed and monitored. Additionally, the system can alternatively or additionally employ acoustics, such as ultrasound or audible triangulation, or wavelengths of light, such as near-infrared imaging, to locate or identify and aim at the vasculature. For example, an IR sensor can be positioned and configured to emit a near-IR beam to identify the targeted fistula or cannulation site. Thus, in various ways, one or more access points within the AV fistula or graft can be suggested or selected for the system, the healthcare provider, or the patient by alternative means. Further, in alternative ways, the system can indicate whether the cannulation was successful and warn the patient or healthcare professional of the success or failure of the cannulation. And furthermore, in another embodiment, the system can alternatively or additionally employ acoustics, such as ultrasound or audible triangulation, or wavelengths of light, such as near-infrared imaging, to identify the patient. Additionally, acoustics or wavelengths of light can be used to register the system relative to the target vasculature.

[0031] In addition, in other aspects, various ways of the cannula insertion system are provided with structures and functions for controllably positioning one or more needles in three-dimensional space and positioning them relative to the target insertion site. In one way, the cannula insertion system includes one or more standard needle cartridge assemblies that can be configured to translate controllably along a support frame that includes a rotatable U-shaped frame that is arranged to position the needles in three-dimensional space and position them relative to the target insertion site. In an alternative embodiment, a support frame including an articulated split frame is provided to independently position two or more needles relative to the insertion site.

[0032] As long as effective cannulation is achieved, various other ways of alternative support frame structures can also be used. For example, a curved arm that supports the needle cartridge and traverses in an arc path, or a structure including a ball-and-socket joint, or other ways that provide multi-axis movement can be employed.

[0033] After reading the details of the systems and methods described more fully below, these and other features of the present disclosure will become apparent to those skilled in the art. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 A schematic diagram showing a hemodialysis procedure and apparatus.

[0035] Figure 2 A top view showing a graft in a first vascular access way.

[0036] Figure 3 A top view showing an AV fistula in a second vascular access way.

[0037] Figure 4 A top view showing cannulation in a second vascular access way.

[0038] Figure 5 A top view showing blood flow caused by cannulation.

[0039] Figure 6 A cross-sectional view showing one way of a reference point.

[0040] Figure 7 A partial perspective view showing a device for implanting a reference point in tissue.

[0041] Figure 8 A schematic diagram showing an anatomical structure containing an implanted reference point.

[0042] Figure 9 and Figure 10 A side view showing the movement of the bones of the forearm.

[0043] Figure 11Side view showing attachment of a marker to bone.

[0044] Figure 12 Schematic diagram showing a scanning system.

[0045] Figure 13 Side view showing blood vessels and a controlled needle insertion path.

[0046] Figure 14 Perspective view showing one way of a cannula insertion system.

[0047] Figure 15 Perspective view showing another way of a cannula insertion system.

[0048] Figure 16A Perspective view showing yet another way of a cannula insertion system.

[0049] Figure 16B To show Figure 16A Perspective view of a system combined with a stabilizer device for use on a patient's arm.

[0050] Figures 17 to 19 Perspective view showing use of a cannula insertion system.

[0051] Figures 20 to 21 Perspective view showing another way of a cannula insertion system. Detailed Description

[0052] Before describing the system and method, it should be understood that the present disclosure is not limited to the specific embodiments described, and thus can of course vary. It should also be understood that the terms used herein are for the purpose of describing particular embodiments only and are not intended as limitations, since the scope of the present disclosure will be limited only by the appended claims.

[0053] In the case where a range of values is provided, it should be understood that, unless the context clearly indicates otherwise, each intermediate value (to one-tenth of the lower limit unit) between the upper and lower limits of the range is also specifically disclosed. Each smaller range between any stated value or intermediate value within the stated range and any other stated value or intermediate value within the stated range is encompassed within the present disclosure. The upper and lower limits of these smaller ranges can be independently included in or excluded from the range, and each range that includes either, neither, or both of the limitations in the smaller ranges is also encompassed within the present disclosure, subject to any specifically excluded limitations in the stated range. In the case where the stated range includes one or both of the limitations, ranges excluding either or both of the included limitations are also included in the present disclosure.

[0054] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, the preferred methods and materials are now described.

[0055] It must be noted that, as used in this specification and the appended claims, unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" include plural referents. Thus, for example, a reference to "a system" includes a reference to one or more systems and equivalents thereof known to those skilled in the art, and the like.

[0056] Reference Figure 1 , shows a hemodialysis system 50 and associated equipment. During hemodialysis, a patient's blood is routed through a dialyzer 52 that filters the blood. The patient is prepared by cleaning the site where the blood exits and returns to the patient's blood vessels. As described more below, steps are taken to prepare the patient's vasculature for dialysis. Once the patient's blood vessels are so prepared, at the start of hemodialysis, a pair of needles 54, 56 are inserted into the patient's arm. An anesthetic can be used to facilitate needle insertion and reduce pain. Each needle is attached to a hose or cannula 58 that is connected to the dialysis system 50. The dialysis system 50 pumps the blood through the dialyzer 52 and returns the blood to the patient. During this process, the dialysis machine monitors and controls the blood pressure, thereby controlling the flow of blood through the filter and the rate at which blood exits and enters the patient.

[0057] When the blood enters the filter, it is forced through a large number of fine hollow fibers. At the same time, the dialysis solution passes around the fibers in the opposite direction. Wastes are thereby removed from the blood and carried away by the dialysis solution. The filtered blood then returns to the patient's vasculature. In this way, excess salts, potassium, calcium, and fluid are removed from the blood.

[0058] An important step before starting a hemodialysis treatment is to perform a procedure to create a vascular access site. Vascular access is a phrase used to describe the location on a patient's body where blood exits and returns to the patient's vasculature during hemodialysis. A hemodialysis vascular access site can be a catheter, an arteriovenous (AV) graft 60 ( Figure 2 ) or an arteriovenous (AV) fistula 70 ( Figure 3 ). It is worth noting that the catheter approach is typically used for temporary access and is not suitable as a permanent solution for home or treatment center dialysis.

[0059] To create an AV graft 60 during an outpatient procedure ( Figure 2) The surgeon incises the skin to access the target blood vessel. The surgeon then uses a synthetic tube graft 60 to connect the artery that carries blood away from the heart to the vein that carries blood to the heart. The surgical site is then closed, leaving the graft available for dialysis. Then, as described above, dialysis needles are repeatedly inserted into the tube during hemodialysis. Generally, the AV graft approach is suitable for patients in whom an AV fistula cannot be formed in the vein because the AV graft approach is more often associated with infection and recurrent thrombosis that can block blood flow and make dialysis difficult or impossible.

[0060] The most widely accepted best long - term vascular access type is the AV fistula 70( Figure 3 ). This approach is characterized by providing the highest blood flow rate for dialysis, being less likely to become infected or clot, and lasting longer than other vascular access approaches. Here, the surgeon directly connects the artery to the vein (usually within the patient's arm) to form an AV fistula. When the vein is connected to the artery in this way, the vein becomes wider and thicker, making it easier to repeatedly place needles for dialysis. The AV fistula itself also has a large diameter, allowing blood to flow out quickly and back into the patient's body, with the aim of creating a system with a large blood flow rate so that the maximum amount of blood can pass through the dialyzer. Figure 4 The cannulation of two needles 54, 56 at the AV fistula site 70 is shown, and Figure 5 the inflow and outflow of blood through the AV fistula 70 during dialysis are shown. It should be noted that when using the presently disclosed cannulation system, the treating healthcare professional can specify any number of treatment protocols and embed them in the software such that the needle cannulation sites can be rotated in a rope - ladder technique or reused as in the buttonhole technique.

[0061] Once a vascular access site has been provided for a patient, the challenge becomes placing the needle within that site. As described above, many patients find it difficult or impossible to cannulate themselves. In addition, inexperienced nurses find cannulation difficult.

[0062] Accordingly, various approaches to access methods and devices have been proposed. The disclosed approaches are configured to provide repeatable, effective, and precise self - cannulation or healthcare - provider - assisted cannulation approaches. The disclosed approaches are intended for use in a central or home environment for hemodialysis.

[0063] The disclosed cannulation system is configured and operative to position one or more needles and, in some embodiments, advance the needles within a target AV graft, fistula, one or more blood vessels. The system further includes functionality to position the needles into the correct position and trajectory and, in some embodiments, advance the needles at a predetermined angle and depth within the patient's body and within the target vasculature. The system is effectively used to provide vascular access and assist with cannulation for the entire body, particularly including for radiocephalic fistulas, brachiocephalic fistulas, and venous transposition fistulas, and can be used from the forearm to the upper arm or other locations on the body. The system can be easily operated by the patient, unskilled personnel, or skilled healthcare workers in a home environment or treatment center and is used to successfully cannulate patients while improving outcomes and reducing complications.

[0064] As described above, as part of a pre-scan process, one or more of an MRI scan, CT scan, ultrasound scan, infrared view, or 3-D photo can be employed to collect information regarding a patient's specific anatomy and vascular morphology. In one embodiment, information regarding the target cannulation site can be collected or stored within the cannulation system memory. This input data regarding the patient's anatomy and vasculature (e.g., anatomical MRI scan, ultrasound scan, CT scan, infrared view, or 3-D photo) is obtained in a manner to register the patient and map the cannulation. The cannulation system controller, including system software and / or firmware, uses this stored patient data to then manage the operation of the structure that guides the cannulation needle.

[0065] In one or more alternative embodiments, the system controller tracks one or more of the insertion site, size, position, and geometry, insertion date, flow rate, treatment frequency, and treatment length and responds to patient health data in order to track and monitor for complications or infection. The system can then recommend an insertion site based on patient usage data, anatomical features, and vascular morphology and provide options regarding needle placement to a nurse or patient. In alternative embodiments, a remote interface or computer is included and is configured to allow a patient or healthcare provider to input patient health information, including heart rate, blood pressure, and blood flow, as well as the patient's diet, medication treatment regimen, and exercise. This patient health information can also be passively collected by connecting to the patient's health device (e.g., via Bluetooth) or integrating with an electronic health record system.

[0066] In an alternative embodiment, the system provides an assessment of the fistula or graft prior to cannulation. In this regard, such functionality may be fully or semi-automated and may further provide communication or alerts to the patient and / or healthcare professional related to the assessment performed by the system. If a blockage is detected, the system will prevent the cannulation procedure and may warn the patient or healthcare provider so that further assessment and / or intervention can be performed. A variety of sensors and actuation mechanisms are provided to automate the assessment process or portions thereof. The sensors may be one or more of acoustic, tactile, ultrasonic, Doppler, infrared, near-infrared, etc.

[0067] In some ways, the system is implemented as one or more sensors that identify tremors or vibrations associated with the cannulation target site, operate like a stethoscope to track bruits (i.e., the sound of the heartbeat or blood flow), or listen for flow to detect blockages. In one or more ways, sensors are provided to sense fluttering or listen for bruits, and the sensors are configured to listen for signs of normal, unobstructed flow or stenosis or thrombus. The sensors may also be equipped to look for other signs of normal flow or blockages, such as problems associated with steal syndrome, and issue an alert if necessary. In one embodiment, a set of sensors may be disposed in a package configured to be manually or automatically translated along the cannulation target site. The package may be implemented in a separate cuff or a structure similar to a stethoscope head, or may be attached to or include a portion of an arm or other structure of the needle support assembly. The system itself or the patient may be prompted to place the sensor package at the cannulation target site and guide the movement of the sensor package to assess the target site. In one way, the positioning of the sensor package may be indicated or controlled by using fiducial markers described below.

[0068] Thus, in certain alternative embodiments, the position of the graft or fistula can be determined and confirmed by using the sensor package. Whether moving automatically or manually, real-time assessment can confirm the position and condition of the graft or fistula. The system can thus be configured to re-adjust the trajectory and / or depth of the needle movement in the event that the patient moves before, during, or between cannulations. The sensor package may be tracked by the same system that tracks the needle cartridge, and the system observes and tracks the position of the sensors relative to when the blood vessel is correctly detected. This information can be used to confirm the position and condition of the cannulation site and can also be fed into the system's database to assist in determining and planning the position of the cannulation site along the graft or fistula.

[0069] In one or more additional or alternative embodiments, the access system may include one or more invisible light, acoustic, pressure, or visual sensors (not shown) for determining and tracking blood flow. The pressure sensor may identify the location of maximum flow to place the needle in an optimal location. The disclosed system may alternatively or additionally incorporate acoustic (e.g., ultrasound or audible triangulation) or a light source providing light wavelengths to locate or identify and target the vasculature (e.g., near infrared). The system or the patient may suggest or select one or more access points within the AV fistula or graft. In these ways, the effectiveness of cannulation and the patient's health may be monitored over time.

[0070] Reference Figures 6 to 8 , shows a way for registering a patient and for fiducial markers for a pre-scan process to develop a cannulation plan or roadmap. It should be understood that the fiducial points may be magnetically or electrically detectable, but electromagnetic, MRI, CT, or ultrasound imaging may also be used so that their position relative to the target vessel can be determined.

[0071] As Figure 6 shown, in one way, the fiducial point may be a marker bead 200 that includes one or more coils 202 that are configured inside the marker bead 200. In a particular aspect, three coils 202 are configured and arranged such that they provide information about the orientation of the marker bead 200 in three-dimensional space (such as relative to the x-y-z orientation axes), as well as information about pitch, roll, and yaw. That is, each coil provides position information about one axis and, in some embodiments, information about pitch, roll, and yaw. Ideally, the fiducial points can be inserted without surgery, but the fiducial points may also be surgically placed when establishing a vascular access site (e.g., an AV graft or fistula).

[0072] In one way ( Figure 7 ), an elongate assembly 210 may be employed to insert the fiducial marker bead 200. A plunger 212 is configured within the needle assembly 210 and arranged to be longitudinally translatable within the elongate assembly 210 to eject one or more marker beads 200 from the distal end of the elongate assembly 210. In a device configured to insert multiple fiducial points, the distal end of the device may be configured to deliver a single fiducial point at a time, such as by including a chamber or equivalent structure for registering a single fiducial point for delivery, while including additional structure for retaining additional fiducial points for subsequent delivery. It may be desirable to implant three fiducial points in the vicinity of the insertion site relative to the target vessel 220 (see Figure 8),or if the fiducial point 200 itself is implemented as a known three-dimensional shape or orientation, only one or two fiducial points may be needed to assist in locating the insertion site on a particular patient. Additionally, when using an electric field in combination with the fiducial points, each fiducial point may include one to three coils that are tuned to different resonant frequencies, allowing their orientation and position to be determined. Thus, once an in-situ scan is performed using electromagnetic, MRI, CT, or ultrasound, a data set is created to precisely locate anatomical structures in three-dimensional space based on the relative positions of the fiducial points.

[0073] After forming and stabilizing the fistula or graft or identifying the target vasculature, the fiducial points may be placed on or near the fistula or graft during a subsequent procedure, or as described below, in bony locations. During this process, the healthcare provider defines the optimal trajectory of the cannula insertion and needle path based on the relative positions of the fiducial points to the target cannula insertion site. The cannula insertion system is used to closely replicate the predetermined position and trajectory path set by the healthcare provider relative to the fiducial points implanted at the vascular access site. These fiducial points are detected by the access system, thereby locating the position of the target blood vessel or graft relative to the fiducial points. The cannula insertion system manages the pitch, roll, and deflection of the holding fixture that supports the standard needle set, as well as the x-y-z axis positioning, such that the needle set moves within an acceptable access path. Thus, the cannula insertion system is conveniently operated to restrict or manage the movement of the needle into an acceptable path to prevent the needle from entering an unacceptable path or inserting beyond a defined end point.

[0074] In a particular manner, the fiducial points are implanted and attached to one or more of the ulna and radius of the forearm. As Figure 9 and Figure 10 shown, when the forearm rotates, the ulna 221 and radius 222 of the forearm move relative to each other. However, the ulna 221 and radius 222 remain useful locations for attaching the fiducial point 200 and provide a reliable reference for the target vasculature for dialysis needle insertion when the forearm is held in the position expected or specified by the access system.

[0075] Referring to Figure 11 , the insertion device 226 is used to pierce the tissue of the forearm and attach one or more fiducial points 200 to one or both of the ulna 221 and radius 222. The insertion device 226 includes an elongate shaft 210 extending from a handle 230. The terminal portion 223 of the shaft 210 defines a needle tip and houses a plunger 212 ( Figure 7 ), which is configured to eject one or more fiducial points 200 from the terminal portion 223 and engage the ulna 221 and radius 222 (see also Figure 7 ).

[0076] As described above, one to three fiducial points can be implanted depending on the type of fiducial point employed and the location where the fiducial point is implanted. The handle 230 is configured to advance the device 226 through tissue and form a cavity in bone or otherwise prepare the bone to receive the fiducial point. The handle 230 is connected to the plunger 212 to effect longitudinal movement of the plunger 212. For example, the handle 230 can be locked during insertion of the device 226 as it advances through tissue and engages the bone and forms an implantation site for the fiducial point 200. The handle 230 is then unlocked, such as by rotating the handle a quarter turn, so that the handle 230 can move longitudinally to advance the plunger and thereby move the fiducial point 200 into fixed engagement with the bone.

[0077] Once the fiducial points are placed as desired, a method configured and arranged to create a three-dimensional image is used to scan the forearm or other body part that includes the implanted fiducial points. This correlates the fiducial point locations with the target vessel location, relative dimensions, and trajectory. This information can then be used to perform cannulation to facilitate access to the target vessel.

[0078] In an alternative embodiment, the cannulation system includes structure and functionality to determine whether one or more implanted fiducial points have migrated. The system detects when a fiducial point is not in the expected location and evaluates whether the displacement of the fiducial point is significant and / or whether it will affect a predetermined cannulation path. For example, the system can measure the displacement of the fiducial point in three dimensions and record the displacement information. The displacement information is then analyzed to determine whether a new or adjusted cannulation path is needed. The cannulation system can also alert the user or healthcare provider so that they are aware of the migration and can consider whether a new or adjusted path is needed and whether other steps should be taken, such as removing and / or replacing the migrated fiducial point.

[0079] In one approach, a scanning system 250 ( Figure 12 ) is used to plan the placement of a vascular access set or kit 252, including a needle or cannula 254, within a target vessel 220 such that it can enter safely at the correct angle and depth. Thus, the scanning system 250 is configured to collect information about the patient by using MRI scanning, CT scanning, ultrasound scanning, infrared view, 3-D photography, or other scans to create an image, such as a three-dimensional image 262, on a computer interface 264 accessible to the user. Also here, information about the target anatomy and / or vasculature is collected or stored in system memory, such as within a data cloud 266.

[0080] Based on a pre-scan process, a roadmap or plan for positioning the vascular access set 252 is provided to the cannula insertion system 320. In some embodiments, the scan system 250 is used to recommend insertion sites based on patient history, system usage data (e.g., previously successful insertion trajectories), and inputs, and to provide the patient with options regarding placement of the needle into the target vascular insertion site 220. In one aspect, the system can manage (but is not limited to) a ladder or buttonhole site strategy for cannula insertion as needed or as directed by the system or a healthcare professional.

[0081] Additionally, in alternative embodiments, the scan system 250 can be configured to allow a patient or healthcare provider to input patient health information, including heart rate, blood pressure, and blood flow, as well as the patient's diet, medication regimen, and exercise, or other data that can impact effective cannula insertion. The system can include Internet and Bluetooth connectivity. The data can also be input passively through connected health devices or an electronic health record system.

[0082] In a particular manner, the scan system 250 includes a scan assembly 285 that includes a bed 286 and also includes a fixation device 288 for holding an arm or other body part 290 relative to the bed 286 in a repeatable and precise manner. Various ways of the fixation device are contemplated with the aim of maintaining an exact orientation of the body part relative to the bed 286. That is, various attachment devices, sleeves, or molded body part receivers can be used as the fixation device. Additionally, the bed 286 can be a simple platform or can be a detection bed implemented in the cannula insertion system as described below. In either case, the bed used during the scan holds or maintains the scanned body part in exactly the same orientation as achieved by the detection bed of the cannula insertion system.

[0083] Once a body part (such as an arm) 290 is placed on the bed 286 and fixed, an MRI scan, CT scan, ultrasound scan, infrared view, 3-D photography, or other scan is performed to collect information for defining and mapping an acceptable access path for cannula insertion to prevent the needle set 252 from entering an unacceptable path or inserting beyond an end point 281 ( Figure 13 ). The acceptable path can be defined by a doctor or mathematically modeled based on the patient's anatomy and implanted fiducial points. Machine learning algorithms can also be used to progressively define the acceptable path throughout the course of treatment, which are applied to trajectory data of previously successful insertions for a given patient and can include the angle of entry into the target blood vessel or graft and paths that avoid certain other anatomical structures.

[0084] The scanning system 250 is thus configured and operative to plan or map the process of placing one or more needles into an access site, AV graft, or fistula. The goal here is to provide a self-cannulation or healthcare provider-assisted cannulation system for the patient that at least defines an acceptable access path 280 into the target vasculature 220 and therein (see Figure 13 ), and prevents the cannulation operator from entering unacceptable paths or inserting beyond a defined endpoint 281.

[0085] In an alternative embodiment, a management system may further be provided, and the management system may also communicate with the dialysis device to further provide feedback regarding cannulation success. In an alternative embodiment, an automatically or medically staff-generated message regarding cannulation success and recommendations regarding any necessary interventions, such as the need for recannulation, may be provided to the patient. A telemedicine video interface for real-time feedback via an Internet connection may be included. Trajectory limitations may also be defined based on the anatomy defined by the patient's ultrasound scan, infrared view, MRI, or CT, or other imaging, such that the system does not allow a trajectory that places the needle in sensitive or non-target anatomy.

[0086] Now referring to Figure 14 , one way of a cannulation system 320 may be implemented as a support frame that includes a pair of hinged L-shaped frames 322, each frame including a track 324 along which a standard access kit 252 may be attached and configured to translate. It should be recognized that the cannulation system 320 need not include such hinged frames, but may implement one or more features of the other ways or their equivalents disclosed herein, so long as the access kit or other needle assembly can be controllably manipulated to effectively cannulate the graft or fistula. Additionally, the cannulation system may include joints or other movable parts, each having only a single degree of freedom, thereby greatly simplifying the mathematics associated with autonomous control of the software or support frame to select the best path toward the target and simplifying the user interface complexity. Further, the system may identify needles from various manufacturers or sources, such as by reading barcodes or other identification information, and may adjust the cannulation procedure for different needle sets.

[0087] In use, the patient simply attaches their arm or other body part within the cannulation system, and the cannulation system can identify the patient and know the acceptable path for the needle to take to effect cannulation. The cannulation system guides the needle to move through the acceptable path, thereby preventing the needle from entering unacceptable paths or inserting beyond the defined endpoint.

[0088] In a preferred manner, the cannula insertion system is servo-controlled, where a servo motor is attached to each moving part of the support frame, and sensors are associated with each servo motor such that a patient or healthcare provider can grasp the needle and move the needle through a path guided or constrained by the servo motor. Here, the sensors detect the precise angular or translational position of the components of the support frame. In another preferred manner, the cannula insertion system is manually operated by a user, and the user sets each movable part of the cannula insertion system according to a predetermined plan. Here, the support frame of the cannula insertion system lacks servo motors or sensors or other electronics. In yet another manner, once the body part is attached to the examination table and the patient is registered, the cannula insertion system operates autonomously to achieve vascular access.

[0089] In a preferred embodiment, the controller of the cannula insertion system is implemented as an array of passive limiters that fix the travel range of each degree of freedom of the needle support structure, and in various ways, a combination of imaging data and information from real-time reference points corresponding to the vascular access target is used to determine information about the settings of each passive limiter and display it on the device. It should be noted that scans can be performed periodically to confirm or modify the positional relationship between the reference point and the target graft or blood vessel based on changing conditions (including selectively changing the access insertion area). Additionally, the operator can move the needle into position, and the system only needs to limit the deviation from the most ideal needle path.

[0090] In an alternative manner, the system can provide tactile feedback such that if a human operator starts to deviate from the optimally defined trajectory, they will feel resistance and can correct back to the expected trajectory within an acceptable tolerance.

[0091] Although it is envisioned to use a standard set of needles, in various alternative embodiments, needle options can be provided to the user based on the patient's anatomy or preference. In this case, the system can be equipped with functionality to understand the differences between the needles so that the position of the needle tip can be determined. Information about the selected needle can be manually entered into the system during the workflow or scanned via a barcode, etc. Multiple devices can also be provided for inserting the needle into the cannula system, such as an actuation button or a joystick or other input system that will advance the needle via patient or other user control. The system can also allow for stepwise advancement of the needle (e.g., once it contacts the skin) or the ability to select the entry speed. Such functionality can be based on patient preference, all within the safety guidelines of the system, including knowing the maximum entry distance and maintaining the desired path. Additionally, the user can be able to physically advance the needle, but subject to system limitations to ensure that the needle does not go too far or deviate from the track. Again here, when the user advances the needle, the system can also provide tactile feedback, sufficient stability, and damping.

[0092] In Figure 14 the illustrated embodiment, the body part holding or attaching device is attached to or incorporated into the examination table 325 of the cannula insertion system 320, and the articulated L-shaped frame 322 is attached to the table 325. The positioning technology is embedded in the table 325 of the cannula insertion system 320 and fixed in relation to the holding device.

[0093] Once the patient's arm is stabilized on the table 325, the position of the fiducial points within the arm is detected and connected via the system software. The position of the fiducial points is compared with a previously recorded 3D data set, and then the position of the vascular access site can be virtually mapped onto the support frame, and the tip of the needle is predicted or pointed to be positioned there. The needle holding clamp is attached to the needle in a fixed and repeatable manner such that the position of the tip of the needle (once fixed into the needle support structure) relative to all anatomical markers is known via the system software. Once the needle is locked into the needle support structure, using the data from the software, the proposed orientation of each degree of freedom of the needle support structure can be calculated.

[0094] In another preferred embodiment, these settings can be communicated to the user via a display and manually set by the user at each joint or moving part of the needle support structure, or the degrees of freedom can be guided by servo motors to guide the user into the desired path for each degree of freedom without any manual input.

[0095] Thus, the real-time positional relationship of the fiducial points relative to the access kit 252 can be observed and compensated for by employing an electromagnetic energy-based navigation system incorporated into the examination table 325, which system identifies and tracks the position of the fiducial points, such as fiducial points implanted in the forearm bone. The predetermined positional relationship between the fiducial points and the cannula insertion system support frame structure is ensured by fixing the arm or other limb to the table 325. This platform can be the same or equivalent device as that used when acquiring (CT or MRI or other) images of the target blood vessel relative to the implanted fiducial points and inputting them into the access system 250. Fixing devices as described above are employed to ensure the expected positional relationship, which is required by the access system 250 or derived from, for example, a CT or MRI scan, i.e., the positional relationship between the body part implanted with the fiducial points 200 and the movable access kit 252.

[0096] In a preferred manner, the servo motor 326 is configured to allow the access kit 252 to move in two directions, i.e., along the base of the L-shaped frame 322 and perpendicular to the base of the L-shaped frame 322. Sensors are associated with each servo motor so that the positioning of the respective moving parts of the support frame can be known.

[0097] In another preferred manner, the cannula insertion system has no electronic devices, and the positioning of the needle is done manually. The manual operation of the support frame of this cannula insertion system can be guided by a pre-scanned plan that instructs the user to place the moving part of the cannula insertion device at a specific angle or position. Additionally, the system will provide the user with instructions on how and in what order to move and place the individual components that support the needle to ultimately achieve the targeted cannulation. Here, angle or longitudinal markings and means for locking the moving part can be provided on the cannula insertion device to assist in correctly positioning the access kit relative to the target.

[0098] Each access kit 252 can be equipped with a stopper 327 to limit the movement of the access kit 252 in a direction generally perpendicular to the base of the L-shaped frame 322 or in a direction determined by the terminal insertion depth point of the blood vessel. As described above, the movement of the components of the support frame can be carried out manually as specified by the system. Additionally, as described above, a servo motor 326 can also be provided at the connection between the L-shaped frame 322 and the bed 325 to control both the rotational movement of the L-shaped frame 322 relative to the bed 325 and the translation of the L-shaped frame 322 along the bed 325. In this way, the access kit 252 can be positioned and advanced according to the instructions of the pre-scanned plan.

[0099] In some manners, one or more servo motors can be omitted or configured for selective operation so that certain steps of moving or positioning the access kit 252 can be done manually. For example, the motor will be configured to support the weight of the system, thus allowing the user to easily manipulate the needle support structure in a smooth manner, but also configured to resist movement through an undesired path. Here, the haptics can be used and adjusted based on the speed or pattern of the user's jig movement.

[0100] As Figure 15 shown, the support frame of the cannula insertion system 330 can alternatively be implemented in a single U-shaped articulated frame 332 having a track 334, and the access kit 252 can be configured to translate along this track. A servo motor 326 can be provided to control the movement of the U-shaped frame 332 relative to the bed 325 and the movement of the access kit 252 relative to the U-shaped frame 332. Devices for fixing the body part implanted with fiducial points to the bed 325 are not shown. Here, the system 330 can also have no electronic devices, and the actions of the individual components of the support frame can be manually controlled to position the access kit relative to the cannula insertion site.

[0101] Reference Figures 16A to 16B, Another alternative of the cannula insertion system 340 includes structures for manipulating and positioning the access kit 252 relative to the target insertion site. Although a single access kit 252 is shown attached to the cannula insertion system 340, the device can be configured to support two access kits 252. Additionally, as with other envisioned cannula insertion systems, the movement of the various components can be servo-controlled or manually controlled or a combination of both.

[0102] In one approach, ball-and-socket joints 342, 343 are configured at the hinge points to enable the device to move the access kit 252 either in accordance with the instructions of the cannula insertion system or manually by a user, such as a patient or a healthcare provider. Servo motors can be configured at the ball-and-socket joints 342, 343 to control the operation, or manually manipulable locking structures can be positioned at the ball-and-socket joints 342, 343 for manual mode, or the cannula insertion system 340 is provided with a combination of automatic and manual functions and associated structures. A first arm 344 extending from the first ball-and-socket joint 342 is connected to a second curved arm 345. The second curved arm 345 includes a track 346 along which the second ball-and-socket joint 343 can translate. Here, the second ball-and-socket joint 343 holds the access kit 252. Similarly, servo motors can be configured at the hinge joints to facilitate the automatic articulated movement of the first arm 344 and the automatic articulated and translational movement of the access kit 252 relative to the track 346 of the second arm 345. Servo motors (not shown) can also be configured to move the access kit 252 substantially perpendicular to the ball-and-socket joint 343 or the curved arm 345. Coordinated system guidance of the various moving parts of the cannula insertion device 340 completes the placement of the access kit 252 into a position above the target insertion point, and then the access kit 252 is advanced as needed within the graft or fistula in accordance with the instructions of the system. Whether the cannula insertion system 340 is configured for automatic or manual control, the system provides this directional coordination.

[0103] As Figure 16BAs shown, a cannula insertion system 340 can be mounted on a base 348 that is configured to engage a body part associated with a target insertion site. In one particular manner, the base 348 can define a stabilizer or expansion element that can be configured to move to stretch, extend, or stabilize the insertion site and the graft or fistula such that it does not roll or otherwise move during cannulation. This movement of the base 348 and application of stabilizing pressure can be performed automatically by the system or manually controlled by an operator. The base 348 can be completely passive or implemented as active arms or supports 349 that move together, separately, downwardly, or at various angles to match the needle insertion trajectory and also apply uniform or non-uniform pressure as the system deems necessary or indicated. In this way, stability of the insertion site can be provided during cannulation. Sensors (not shown) can also be provided such that force feedback is communicated directly or through the system to the cannula insertion system and the operator.

[0104] Now turning to Figures 17 to 19 , Figure 14 the cannula insertion system 320 is shown for inserting the needle 254 of the access kit 252 into a target vasculature. Such use can be for providing vascular access for hemodialysis. Additionally, certain functions can be servo-motor controlled by the system or performed manually in other ways as described herein.

[0105] Once the positional relationship of the implanted reference points relative to the target blood vessel or graft for cannulation is established and the terminal depth of needle insertion is established and stored within or communicated to the system, the body part or arm 290 is placed on the bed of the cannula insertion system 320. As previously described, the arm 290 can be restricted on the bed 325 (not shown) to provide an accurate and repeatable orientation of the arm 290 relative to the bed 325. With the arm 290 positioned on the bed 325 as needed and indicated, the system identifies the patient and knows the path the needle is to take to complete cannulation. In one manner, the first L-shaped frame 322 carrying the access kit 252 moves along the bed 325 and the access kit 252 moves relative to the L-shaped frame 322 to position the needle 254 of the access kit 252 within the graft or blood vessel 60, 70 ( Figure 18 ). The depth of movement of the access kit 252 is controlled by the system 320 and can be limited by a stop 327 attached to the access kit 252.

[0106] In an alternative embodiment, once cannula insertion is achieved, the system can confirm successful cannula insertion. The system can prompt the patient or healthcare provider as to whether the cannulation has been successful and may issue an alert if the cannulation is not successful. The sensor package described above can then be used to continue observing the cannulation to confirm that all is well, including providing visual confirmation of the presence and location of the needle. Again here, one or more acoustic sensors can provide sound information regarding flow, and IR can provide visual flow information, and a pressure sensor or visual sensor can be provided on the back of the needle or tubing to look for flashback and pulsatile blood. The pull-back of the needle plunger can be automatic or manual.

[0107] The now inserted access kit 252 can be disengaged from the L-shaped frame 322 and connected to tubing leading to the hemodialysis system (see, for example, Figure 1 ). Next ( Figure 19 ), the second L-shaped frame 322 is manipulated to position the needle 254 of the second access kit 252 within the target graft or vessel 60, 70 as required and directed by the system 250. Such movement may require the L-shaped frame 322 to rotate relative to the bed 325 and move along the bed 325 both, as well as the access kit 252 to move relative to the L-shaped frame 322. After the needle 254 has been placed within the vessel or graft 60, 70 as required and the cannula insertion has been confirmed correct, the second access kit 252 can also be disengaged from the L-shaped frame 322 and connected to the hemodialysis system via tubing. Dialysis can then be initiated as previously prescribed or directed by the doctor.

[0108] Reference Figures 20 to 21 , in an alternative embodiment, a cannula insertion system 400 can be provided that includes a hand-held needle insertion assembly 402, thereby implementing the components required to align the needle trajectory with the desired path. The cannula insertion system 400 can include both mechanical and electrical components required to manipulate the needle trajectory and sensing capabilities that assist in the fine positioning of the needle during insertion. In one particular aspect, the hand-held needle insertion assembly 402 is configured to facilitate effective and efficient access to challenging anatomies due to its size and minimal degrees of freedom.

[0109] The cannula insertion system 400 can also include a user interface 404 that allows a technician to interact with the hand-held needle insertion assembly 402; a monitoring and positioning probe 406 that is used to collect information regarding the target anatomy (such as location, blood flow information, etc.); and an articulated mounting arm 408 that is designed to stabilize the hand-held needle insertion assembly 402. A cart 410 can also be provided and is configured to house a processing computer and control system that is designed to coordinate the actions of the various components of the cannula insertion system 400. The cart 410 can also house the components required to provide power and data transfer to the remainder of the system 400.

[0110] In one aspect, the cannula insertion system 400 can be implemented as a hand-held robot or needle insertion assembly 402 mounted on a passive arm 408, which can be positioned and locked in place by a user or technician. The hand-held robot or needle insertion assembly 402 for delivering the needle is designed to be small and can incorporate functions and structures that provide the degrees of freedom required to position and align the needle during insertion and to insert the needle into the target blood vessel. The hand-held robot or needle insertion assembly 402 can include on-board light- or sound-based sensing (such as near-infrared or ultrasonic) that is designed to provide fine positioning information and assist with needle placement. The monitoring and positioning probe 406 can be configured to cooperate with the hand-held robot or needle insertion assembly 402 and provide acoustic- or light-based information that can monitor blood flow, pulse, etc., or can also be used to locate blood vessels by means of near-infrared light and associated processing capabilities. As previously described, the cart 410 can also include processing capabilities and provide power and data processing / communication capabilities.

[0111] Specifically referring to Figure 21 , the hand-held needle insertion assembly 402 is a small portable device and can incorporate mechanisms required to position, align, and insert the needle along a defined or desired path or trajectory. The hand-held robot or needle insertion assembly 402 is electrically connected to a power supply and a data processing unit and can be connected to or handled independently of the support or mounting arm 408. The monitoring and positioning probe 406 provides information to coordinate the movement of the needle and provides data on the target anatomy. In one embodiment, the hand-held needle insertion assembly 402 can also incorporate a positioning probe for assisting with fine positioning and trajectory correction. Light- or acoustic-signal-based methods can be used to generate the information required for monitoring or positioning.

[0112] Accordingly, a system and method are proposed for accessing blood vessels in a consistent manner without the need for a technician. In one embodiment, such a system can include implantable fiducial points that are one or more of passive, active, or activatable. The system includes a detection scheme for positioning the fiducial points in three-dimensional space and a function designed to co-register these three-dimensional positions with a previously stored three-dimensional data set containing relative position information about the target blood vessel. The stored data is retrieved and co-registered with the three-dimensional positions of a previous access operation, and the site is reused or a new desired access point is determined. Other means that employ sensors without fiducial points can also be used to locate the cannula insertion site. Next, a guideway device and system are used to place the access kit into the target blood vessel at the desired orientation, depth, and position.

[0113] As described above, in each or one or more of the disclosed embodiments and modes, the patient can move the components of the system and advance the needle on their own, taking into account their own sensations, pain, or comfort level, where the system ensures that the needle does not take the wrong path or is inserted too deeply beyond a defined and desired endpoint. Additionally, in each or one or more of the disclosed embodiments and modes, the system can automatically position, aim, and advance the needle during the cannulation procedure. Further, in one or more of the disclosed embodiments and modes, the patient and the system can work together in different degrees and various ways, such as where the patient has the system automatically position the needle but wants to push the needle into the vascular access site, or where the patient moves the structure holding the needle and has the system push the needle into the vascular access site when the system is ready or when the patient indicates that they are ready and signals that cannulation should occur.

[0114] In alternative embodiments, real-time participation of a telemedicine professional can be provided so that cannulation can be remotely visualized and guided, or the healthcare professional can provide remote advice or information regarding the cannulation procedure. An internet connection, including a telemedicine video connection, can be used for real-time guidance of the system, troubleshooting, and advice regarding the insertion path. In another alternative embodiment, an augmented reality system can also be incorporated into the system to collect patient data and display real-time guidance for both the positioning of the cannulation needle or other components of the access device.

[0115] Although the present disclosure has been described with reference to specific embodiments thereof, those skilled in the art will understand that various changes can be made and equivalents can be substituted without departing from the true spirit and scope of the present disclosure. Additionally, many modifications can be made to adapt a particular situation, material, composition of matter, process, process step, or step to the purposes, spirit, and scope of the present disclosure. All such modifications are intended to be within the scope of the present disclosure.

Claims

1. A system for positioning a needle into a patient's vascular access site, which comprises: a needle insertion device; a needle holding clamp attached to the needle insertion device; wherein the system guides the needle to move through an acceptable access path and prevents the needle from moving through an unacceptable path or from inserting the needle beyond a defined end point.

2. The system according to claim 1, wherein one or more fiducial points are implanted in the patient's body.

3. The system according to any one of the preceding claims, further comprising a structure for attaching a body part to an examination table.

4. The system according to claim 3, wherein the examination table senses the one or more fiducial points.

5. The system according to any one of the preceding claims, wherein the system registers the patient in response to sensing the one or more fiducial points.

6. The system according to any one of the preceding claims, wherein once the patient fixes a body part to the examination table, the system identifies the patient and, based on a predetermined identification of the cannula insertion site and the path to the cannula insertion site, the system knows the acceptable access path through which the needle can move.

7. The system according to any one of the preceding claims, wherein the system is configured to be connected to a hemodialysis system.

8. The system according to any one of the preceding claims, wherein one or more of MRI scans, CT scans, ultrasound studies, infrared views, and 3-D photography are used to provide information about the patient's anatomy and to develop a roadmap for creating the acceptable access path to be taken by the needle.

9. The system according to any one of the preceding claims, wherein the vascular access site is an AV fistula.

10. The system according to any one of the preceding claims, wherein the vascular access site is an AV graft.

11. The system according to any one of the preceding claims, wherein the system guides or restricts the path that a support frame can take.

12. The system according to any one of the preceding claims, wherein the patient is scanned periodically to develop a roadmap for creating the acceptable access path to be taken by the needle.

13. The system according to any one of the preceding claims, the support frame further comprising a plurality of articulated or movable joints.

14. The system according to any one of the preceding claims, further comprising a servo motor and sensors associated with the servo motor and configured at one or more of the articulated or movable joints.

15. The system according to any one of the preceding claims, wherein the system is operated completely manually and has no electronic components.

16. The system according to any one of the preceding claims, the support frame further comprising a pair of articulated L-shaped frames.

17. The system according to any one of the preceding claims, the support frame further comprising a U-shaped frame.

18. The system according to any one of the preceding claims, the support frame further comprising a curved arm and one or more ball-and-socket joints.

19. The system according to any one of the preceding claims, wherein the system provides a small range of acceptable paths and the most desired path.

20. The system according to any one of the preceding claims, wherein access to the fistula or graft location is provided, including one or more of the radial artery, brachiocephalic vein, and vein transposition location.

21. The system according to any one of the preceding claims, wherein the real-time positional relationship of the one or more fiducial points relative to the needle is observed and compensated for by an electromagnetic energy-based navigation system incorporated into the examination table, the navigation system identifying and tracking the positions of the one or more fiducial points, such as fiducial points implanted in the bones of the forearm.

22. The system according to any one of the preceding claims, further comprising an array of passive limiters that fix the stroke range of each degree of freedom of the needle and use a combination of imaging data and information from real-time fiducial points corresponding to the vascular access target to determine information about the settings of each passive limiter and display it on the device.

23. The system according to any one of the preceding claims, wherein the positions of the one or more fiducial points within the arm are detected, the positions are connected via system software, compared with a previously recorded 3D data set, and then the position of the vascular access site is virtually mapped to the position where the support frame and the needle are guided to be positioned.

24. The system according to any one of the preceding claims, wherein the system manages or provides an assessment of the fistula or graft prior to cannulation.

25. The system according to any one of the preceding claims, wherein if an obstruction is detected, the system prevents the cannulation procedure.

26. The system according to any one of the preceding claims, wherein if an obstruction is detected, the system issues an alert to the patient or healthcare provider.

27. The system according to any one of the preceding claims, wherein the system provides an automatic assessment of the graft or fistula.

28. The system according to any one of the preceding claims, wherein the assessment of the target insertion site involves identifying one or more of vibrations, bruits, or sounds associated with flow or obstruction.

29. The system according to any one of the preceding claims, further comprising fiducial markers configured to be attached to the radius or ulna.

30. The system according to any one of the preceding claims, further comprising a sensor package configured to perform one or more of the following: localize or assess a fistula or graft prior to cannulation, or assess the status of cannulation.

31. The system according to any one of the preceding claims, further comprising one or more invisible light, acoustic, pressure, or visual sensors for determining and tracking blood flow.

32. The system according to any one of the preceding claims, further comprising an IR sensor configured to identify the target site.

33. The system according to any one of the preceding claims, wherein the needle holding fixture is implemented in an arm that supports the needle cartridge, and the support structure includes one or more ball-and-socket joints that facilitate movement of the needle cartridge relative to the target insertion site as needed.

34. The system according to any one of the preceding claims, wherein the end point resides within the wall defining the target graft or blood vessel.

35. The system according to any one of the preceding claims, wherein the system provides a real-time assessment of the cannulation procedure.

36. The system according to any one of the preceding claims, wherein the controller is an array of passive limiters that fix the travel range of each degree of freedom of the needle holding fixture.

37. The system according to the preceding claim, wherein a combination of imaging data and information from real-time reference points corresponding to the vascular access target is used to determine information about the settings of each passive limiter and display it on the device.

38. The system according to any one of the preceding claims, wherein the operator guides a part of the path of the needle, and the system guides or restricts a part of the path of the needle.

39. The system according to any one of the preceding claims, wherein the system provides instructions to the operator regarding positioning of the needle by instructing the operator to move one or more components of the support frame to various positions to complete cannulation of the vascular access site.

40. The system according to any one of the preceding claims, wherein the system is configured to readjust the trajectory or depth of needle insertion if the patient moves before or during cannulation.

41. The system according to any one of the preceding claims, wherein the system is capable of automatically positioning, aiming, and advancing the needle during the cannulation procedure.

42. A system for positioning one or more needles relative to a patient's vascular access site, which comprises: a support frame; and a needle attached to the support frame; wherein each degree of freedom of movement of the support frame is manually set based on information provided by system software that restricts movement of the needle along an acceptable access path within the patient's body.

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