System for hemodialysis autocannulation

EP4746794A2Pending Publication Date: 2026-05-27MOZARC MEDICAL US LLC

Patent Information

Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
MOZARC MEDICAL US LLC
Filing Date
2024-07-17
Publication Date
2026-05-27

AI Technical Summary

Technical Problem

Current hemodialysis systems face challenges in accurately and safely inserting cannulation needles into AV fistulas, leading to issues such as infiltrations, hematoma formation, infection, and aneurysms, which can result in morbidity, hospitalizations, and loss of access.

Method used

The system employs one or more ultrasound sensors in communication with a processor to control the delivery of cannulation needles, determining the target vessel location, depth, and orientation, and adjusting the needle delivery based on real-time data from the sensors.

Benefits of technology

This approach enables precise and safe insertion of cannulation needles, reducing the risk of complications and improving patient safety and comfort by ensuring accurate placement and minimizing manual error.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

Systems, components, and methods are provided for delivering one or more cannulation needles into a vessel. The systems, components and methods use a needle delivery device coupled to one or more ultrasound sensors to control delivery of the cannulation needles.
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Description

SYSTEM FOR HEMODIALYSIS AUTOCANNULATIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Application No. 63 / 527,308, entitled “SYSTEM FOR HEMODIALYSIS AUTOCANNULATION,” filed on July 17, 2023, the entire contents of which are hereby incorporated by reference.FIELD

[0002] Systems, components, and methods are provided for delivering one or more cannulation needles into a vessel. The systems, components and methods use a needle delivery device coupled to one or more ultrasound sensors to control delivery of the cannulation needles.BACKGROUND

[0003] Hemodialysis treatment requires that a patient have a vascular access, an accessible entry site into the blood stream. Options for long term access include arteriovenous (AV) grafts or AV fistulas. Successful access cannulation is important for effective hemodialysis treatment. However, an increasing number of patients have difficult AV fistula cannulation or may be performing dialysis at home and therefore need to self-cannulate. Miscannulation of vascular access can cause infiltrations, hematoma formation, infection, and aneurysms. These problems can lead to morbidity, hospitalizations, access revision, and even loss of access. Hence, there is a need for systems and methods to reduce the burden of cannulation. There is a further need for systems that can accurately insert a cannulation needle to ensure patient safety and comfort. The need extends to automated cannulation systems that use sensors to ensure the proper delivery and placement of a cannulation needle for each insertion.SUMMARY

[0004] The problem to be solved is to deliver a cannulation needle accurately and safely into a fistula of a patient. The solution is to use one or more ultrasound sensors in communication with a processor to control delivery of the cannulation needle.

[0005] The first aspect relates to a system. The system can include a needle delivery device connectable to at least one cannulation needle; at least one ultrasound sensor; and a processor in communication with the at least one ultrasound sensor; the processor programmed to determine a target vessel location, a target vessel depth, and a target vessel orientation; the processor programmed to control delivery of the cannulation needle based on data from the at least one ultrasound sensor.

[0006] In some embodiments, the at least one ultrasound sensor can include an array of ultrasound sensors.

[0007] In some embodiments, the array of ultrasound sensors can include ultrasound sensors at multiple angles.

[0008] In some embodiments, the system can include 3-D accelerometers to determine an angle of each of the ultrasound sensors with respect to a patient skin.

[0009] In some embodiments, an angle of each ultrasound sensor can be adjustable.

[0010] In some embodiments, the system can include 3-D accelerometers to control an angle of each of the ultrasound sensors with respect to a patient skin.[0001 1] In some embodiments, the needle delivery device can be connectable to at least two cannulation needles.

[0012] In some embodiments, the needle delivery device can include a motor; and the processor can be programmed to control the motor to advance the cannulation needle into a target position within the target vessel.

[0013] In some embodiments, the system can include a depth sensor in communication with the processor; the processor programmed to, after delivery of the cannulation needle, determine whether the cannulation needle was delivered to a proper depth.

[0014] In some embodiments, the depth sensor can include an impedance sensor, an ultrasound sensor, a temperature sensor, and / or a flow sensor.

[0015] In some embodiments, the system can include a skin temperature sensor in communication with the processor; the processor programmed to determine a fistula health based on the skin temperature sensor.

[0016] In some embodiments, the system can include a camera to take a picture of a fistula before and after cannulation.

[0017] In some embodiments, the processor can be further programmed to determine a flow through the target vessel and to determine a target position based on the flow through the target vessel.

[0018] In some embodiments, the system can include a controller in communication with the processor; wherein the processor is programmed to control the motor to advance the cannulation needle based on the controller.

[0019] In some embodiments, the processor can be programmed to determine a needle location within the target vessel.

[0020] In some embodiments, the processor can be programmed to determine a needle insertion angle and / or needle insertion speed.

[0021] The features disclosed as being part of the first aspect can be in the first aspect, either alone or in combination, or follow any arrangement or permutation of any one or more of the described elements. Similarly, any features disclosed as being part of the first aspect can be in a second aspect described below, either alone or in combination, or follow any arrangement or permutation of any one or more of the described elements.

[0022] The second aspect relates to a method. In some embodiments, the method can include receiving data from at least one ultrasound sensor; determining a target vessel location, a target vessel depth, and a target vessel orientation based on the data from the at least one ultrasound sensor; and controlling delivery of a cannulation needle loaded in a needle delivery device based on data from the at least one ultrasound sensor.

[0023] In some embodiments, the at least one ultrasound sensor can include an array of ultrasound sensors.

[0024] In some embodiments, the sensor array can include ultrasound sensors at multiple angles.

[0025] In some embodiments, the method can include determining an angle of each of the ultrasound sensors with respect to a patient skin using one or more 3D accelerometers.

[0026] In some embodiments, an angle of each ultrasound sensor can be adjustable.

[0027] In some embodiments, the method can include controlling an angle of each of the ultrasound sensors with respect to a patient skin using one or more 3D accelerometers.

[0028] In some embodiments, the method can include controlling delivery of a second cannulation needle loaded in the needle delivery device.

[0029] In some embodiments, the method can include determining whether the cannulation needle was inserted to a proper depth using a depth sensor.

[0030] In some embodiments, the depth sensor can include an impedance sensor, an ultrasound sensor, a temperature sensor, and / or a flow sensor.

[0031] In some embodiments, the method can include determining a fistula health based on a skin temperature sensor.

[0032] In some embodiments, the method can include determining a flow through the target vessel and determining a target needle location based on the flow through the target vessel.

[0033] In some embodiments, the method can include determining a needle location within the target vessel.

[0034] In some embodiments, the method can include determining a needle insertion angle and / or needle insertion speed.

[0035] The features disclosed as being part of the second aspect can be in the second aspect, either alone or in combination, or follow any arrangement or permutation of any one or more of the described elements. Similarly, any features disclosed as being part of the second aspect can be in the first aspect, either alone or in combination, or follow any arrangement or permutation of any one or more of the described elements.BRIEF DESCRIPTION OF THE DRAWINGS

[0036] FIG. 1 shows controlling delivery of a cannulation needle, according to some embodiments.

[0037] FIG. 2 shows an image of a target vessel, according to an embodiment, according to some embodiments.

[0038] FIGS. 3 A - 3B show orientations of a sensor with respect to a target vessel, according to some embodiments.

[0039] FIG. 4 shows the use of a cannulation needle, according to some embodiments.DETAILED DESCRIPTION

[0040] Unless defined otherwise, all technical and scientific terms used have the same meaning as commonly understood by one of ordinary skill in the art.

[0041] The articles “a” and “an” are used to refer to one to over one (i.e., to at least one) of the grammatical object of the article. For example, “an element” means one element or over one element.

[0042] A “3-D accelerometer” is a sensor that can detect motion in three mutually perpendicular axes.

[0043] The term “adjustable” refers to a variable or state of a system that can be altered.

[0044] The term “advance,” when referring to delivery of a needle, refers to moving the needle towards a target location within a vessel, either within the body of a patient or outside the body of the patient towards the skin of the patient.

[0045] The term “angle” refers to a relative direction of two components or lines.

[0046] An “array” of sensors is a set of two or more sensors.

[0047] An “autocannulation system” is a set of components that use automated processes to deliver cannulation needles into a vessel of a patient.

[0048] The term “camera” refers to a device capable of obtaining an optical picture of a system.

[0049] A “cannulation needle” is a thin hollow tube through which blood within a patient’s blood vessels can be accessed.

[0050] The terms “communication” or “communicating” refer to the ability to transfer electronic information, either through a wired connector or wirelessly.

[0051] The term “comprising” includes, but is not limited to, whatever follows the word “comprising.” Use of the term indicates the listed elements are required or mandatory but that other elements are optional and may be present.

[0052] The terms “connected,” “connection,” to “connect,” or “connectable” refers to the ability of forming physical contact between two components or parts. The connection need not be permanent.

[0053] The term “consisting of’ includes and is limited to whatever follows the phrase “consisting of.” The phrase indicates the limited elements are required or mandatory and that no other elements may be present.

[0054] The term “consisting essentially of’ includes whatever follows the term “consisting essentially of’ and additional elements, structures, acts, or features that do not affect the basic operation of the apparatus, structure or method described.

[0055] The terms “control,” “controlling,” or “controls” can refer to the ability of one component to direct the actions of a second component.

[0056] A “controller” is a device which monitors and affects the operational conditions of a given system. The operational conditions are typically referred to as output variables of the system wherein the output variables can be affected by adjusting certain input variables.

[0057] The term “delivery,” when referring to a needle, refers to the insertion of the needle into a patient’s body.

[0058] The term “depth” refers to a distance of a component below a surface or within a vessel.

[0059] A “depth sensor” refers to a sensor capable of determining a distance of a component beneath a surface or within a vessel.

[0060] The term “determine” or “determining” refers to ascertaining a state of a system, component, or subject.

[0061] The term “fistula health” refers to the physiological health of a fistula inside the body of a patient.

[0062] The term “flow” refers to the movement of a fluid or gas.

[0063] A “flow sensor” is a sensor capable of determining the velocity or volume of a fluid moving through a conduit or system.

[0064] An “impedance sensor” is a sensor capable of determining the electrical impedance of a material.

[0065] A “motor” is a device or component that supplies motive power for a system.

[0066] A “needle delivery device” is a set of components that cause a needle to pierce the skin of a patient.

[0067] The term “needle insertion angle” refers to the angle formed between a shaft of a needle and the skin of a patient.

[0068] The term “needle insertion speed” refers to the velocity of a needle while the needle is inserted into a patient.

[0069] The term “needle location” refers to the actual physical location of a needle.

[0070] The term “patient skin” refers to the outer portion of the body of a patient.

[0071] The term “processor” refers to any programmable or configurable logic circuit, which can be configured to execute a desired algorithm. A processor can provide a generalized instruction set, such as in the case of a microprocessor or microcontroller or can be configured in hardware as in the case of an application-specific integrated circuit (FPGA). In some cases, processors can be emulated and / or virtualized. For example, virtualization technology can provide a virtual processor running under a hypervisor, or other kind of virtualization layer, in which case the “processor” can include the emulation layer, as well as the physical processor that ultimately executes the instructions.

[0072] The term “programmable” or “programmed” refers to an electronic system that can receive instructions to perform specified actions.

[0073] The term “receiving” data refers to obtaining data from any source by any method.

[0074] The term “target vessel” refers to a blood vessel into which a cannulation needle is to be inserted.

[0075] A “target vessel depth” is the distance between the outer layer of skin of a patient and a specified target vessel.

[0076] A “target position” is a location within a target vessel into which a needle is to be inserted.

[0077] A “target vessel location” refers to the position of a target vessel within the body of a patient.

[0078] A “a target vessel orientation” is the direction along which a target vessel extends.

[0079] A “temperature sensor” is a sensor capable of determining the temperature of a material.

[0080] An “ultrasound sensor” is a sensor that can detect sound waves of a specified frequency.Autocannulation System

[0081] FIG. 1 shows a use of an autocannulation system 100, according to some embodiments. As illustrated in FIG. 1, a cannulation needle 101 can be inserted through the skin 103 of a patient, with a tip 102 of the cannulation needle 101 capable of being placed within a target vessel (not shown). The system can include one or more ultrasound sensors, such as ultrasound sensor 104, ultrasound sensor 105, and ultrasound sensor 106. As illustrated in FIG. 1, multiple ultrasound sensors can be arranged in a sensor array. In some embodiments, a single ultrasound senor can be used. One of skill in the art will understand that any number of ultrasound sensors can be used, including 1, 2, 3, 4, 5, or more ultrasound sensors. In some embodiments, at least one ultrasound sensor 104, 105 can be used. In some embodiments, a plurality of ultrasoundsensors 104, 105, 106 can be used. The ultrasound sensors 104, 105, 106 can be in communication with a processor (not shown) of the autocannulation system 100. The processor can be programmed to receive data from the ultrasound sensor 104, ultrasound sensor 105, and / or ultrasound sensor 106 to determine the precise position of the tip 102 of the cannulation needle 101, as well as the target vessel. Although stated as ultrasound sensors 104, 105, and 106, it should be understood that the sensors 104, 105, and 106 can be any type of electromagnetic sensor capable of emitting electromagnetic waves or energy.

[0082] In certain embodiments, the processor can be connected to a display (not shown). The display can show the user the precise location of the cannulation needle 101 as the cannulation needle 101 enters the patient skin 103. For example, the user can view the cannulation needle 101 moving through the patient skin 103 and towards the target vessel. The target vessel can also be imaged using the one or more ultrasound sensors 104, 105, 106, providing the user with a clear picture of the insertion of the cannulation needle 101 into the target vessel.

[0083] Using at least one of the ultrasound sensors 104, 105, 106, the tip 102 of the cannulation needle 101 can be viewed. The echo of the tip 102 of the cannulation needle 101 can be visualized by diffraction of ultrasound, which can scatter uniform waves with a relatively low amplitude in different directions. The shaft of the cannulation needle 101 can be visualized by reflection, as the shaft of the cannulation needle 101 is largerthan the wavelength of the ultrasound, creating acoustic shadow 107. By the rule of reflection, the shaft echo is maximized when ultrasound strikes the cannulation needle 101 at angles approaching 90°, which makes visualization of the shaft possible even in hyperechoic subcutaneous tissue. As such, the angle between ultrasound sensor 104, ultrasound sensor 105, and ultrasound sensor 106 and the cannulation needle 101, shown as angle 108 in FIG. 1, can be kept at or near 90°. However, other angles can be used with lower reflection from the shaft of the cannulation needle 101. In some embodiments, different angles can be used for each sensor in an ultrasound array, allowing viewing of the cannulation needle 101 and target vessel from multiple angles. In some embodiments, the angle of the ultrasound sensors can be adjustable. The processor can determine the angle of each ultrasound sensor by any means known in the art. For example, 3-D accelerometers can be used to determine the angle of each ultrasound sensor. The angle of each ultrasound sensor with respectto the patient skin can thus be accurately controlled. In some embodiments, the cannulation needle 101 can have an echogenic coating to improve needle visualization.

[0084] A needle delivery device (not shown in FIG. 1) can place the cannulation needle 101 into the target vessel. The needle delivery device can include a motor to move the cannulation needle 101 into the target vessel and adjust the delivery angle and entry location. The processor, receiving data from the ultrasound sensors, can determine the precise location of the cannulation needle 101 and target vessel to control delivery. The processor can be programmed to determine a proper needle insertion angle and / or needle insertion speed to accurately and safely place the cannulation needle 101 into the target vessel. For example, the processor can impact patient outcomes by improving the placement accuracy of the cannulation needle 101. In some embodiments, the system can include a controller for the needle delivery device. For example, the user can view the placement of the needle and the target vessel and use the controller to accurately deploy the device. In some embodiments, the autocannulation system 100 can be connected to an external display to aid in placement of the cannulation needle 101. In some embodiments, an app, joystick, or other component can be used as the controller by the user. In some embodiments, the needle deployment can be automated, with the processor programmed to receive data from the ultrasound sensors and accurately place the cannulation needle 101. In some embodiments, the speed of needle insertion can be set at a rate with which the patient is comfortable. For example, the speed of needle insertion can be set at a rate comparable with normal manual insertion of a cannulation needle 101. In some embodiments, the system can use faster or slower speeds depending on the comfort of the user. In some embodiments, the speed of insertion can be adjusted by the user, the patient, or combination thereof.

[0085] In some embodiments, the ultrasound sensors 104, 105, 106 can be physically coupled to the needle delivery device. For example, an armband or other device can be used to couple the needle delivery device and ultrasound sensors 104, 105, 106. Physically coupling the needle delivery device to the ultrasound sensors 104, 105, 106 can allow the processor to determine the distance of the needle tip and angle of the needle approach relative to at least one of the sensor array, sensor located vessel, and target vessel site. The needle delivery device can include one or more cannulation needles. For example, a needle delivery device can be loaded with two cannulation needles, allowing for placement of multiple needles. In some embodiments, the twoneedles can be orientated in a retrograde arrangement, with the needles inserted in opposite directions into the target vessel. In some embodiments, the needles can be orientated in an antegrade position, with both needles inserted in the same direction with respect to the target vessel.

[0086] FIG. 2 illustrates the use of ultrasound sensors 104, 105, 106 to facilitate visualization of a target vessel 205. A transducer 201 having an ultrasound sensor 104, 105, 106 or an array of ultrasound sensors can be placed on the skin 202 of the patient. The ultrasound can penetrate the epidermis 203 and dermis 204 to the target vessel 205. A portion of the ultrasound will be reflected by the anterior wall 206 and posterior wall 207 of the target vessel 205. The ultrasound sensors on transducer 201 can detect the reflection from anterior wall 206 and posterior wall 207 of the target vessel 205 to determine the precise target vessel depth, target vessel orientation, and target vessel location of the target vessel 205, aiding in cannulation needle placement. Using data from the ultrasound sensors, the processor of the system can determine the target vessel location, depth, orientation, etc. to determine a target location for the canulation needle 101. The images acquired by the ultrasound sensors 104, 105, 106 can be processed through artificial intelligence (‘Al’) or standard image processing software known in the art to identify the underlying target vessel 205. In some embodiments, the delivery system can be oriented to or guided by a marker on the patient, including a tattoo, birth mark, scar, marker(s) embedded on the implanted AV graft to assist placement of the needle. As illustrated in FIG. 2, the ultrasound sensor array can be manufactured with wafer-based manufacturing technology on a flexible transducer substrate that can be reused or discarded after a single use.

[0087] FIG. ’ s 3 A and 3B illustrate the use of ultrasound sensors to place a cannulation needle 302. In each of FIG.’s 3A and 3B, the system can use an ultrasound sensor 303 to determine the location of the cannulation needle 302 and target vessel 301. In FIG. 3A, the ultrasound sensor 303 is oriented transversely to the cannulation needle 302, with the beam 304a perpendicular to the target vessel 301. In contrast, FIG. 3B illustrates the ultrasound sensor 303 longitudinal to the cannulation needle 302, with the beam 304b parallel to the target vessel 301.

[0088] Using the transverse orientation illustrated in FIG. 3A, the user can see the entire circumference of the target vessel 301. Seeing the entire circumference of the target vessel 301 is useful in placing the cannulation needle 302 into small vessels, such as small veins by enablingthe user to enter the target vessel 301 directly on top of the target vessel 301. Highly precise cannulation is possible by scanning the target vessel 301 dynamically with coordinated advance of the cannulation needle 302.

[0089] In some embodiments, a 2D array of ultrasound sensors can be used. The 2D array of ultrasound sensors can be positioned either in a transverse orientation or in a perpendicular orientation. Using a 2D array of ultrasound sensors can improve visualization of the cannulation needle during insertion.

[0090] FIG. 4 shows the use of the autocannulation system 100. An ultrasound sensor 403 is placed on the skin 401 of the patient above a target vessel 402. In some embodiments, the system can be guided by a marker on the patient, including a tattoo, birth mark, scar, marker(s) embedded on the implanted AV graft to determine the general position of the target vessel 402 and / or the location within the vessel for insertion. A cannulation needle 404 can then be inserted into the target vessel 402 as guided by data from the one or more ultrasound sensors 403.

[0091] The skin entry site 406 can be determined by the processor (not shown) of the system. The skin entry site 406 is based on the depth of a target position within the target vessel 402, shown as depth D in FIG. 4, and the angle of the cannulation needle 404 with respect to the skin 401, shown as angle q in FIG. 4. Generally, the target position will be the center of the target vessel 402 and at an angle as close as possible to parallel with the direction of the target vessel 402. The distance between the edge of the ultrasound sensor 403 and the specific ultrasound generating site 407 may vary between probes. In some embodiments, the distance between the edge of the ultrasound sensor 403 and the specific ultrasound generating site 407 can be about 3 mm to about 5 mm. In some embodiments, this distance can be about 4 mm, as shown in FIG. 4. The system can determine or otherwise receive this distance during calibration.

[0092] In some embodiments, the system 100 can incorporate data from previous cannulations to select a target insertion site. For example, previous images collected by the system, which can include ultrasound images from previous cannulations or any other imaging, as well as previous insertion sites, previous target vessel locations, and the resultant flow or dialysis results from the previous target locations can be input into the system or saved by the system. This information can, in some embodiments be used as an input to automatically select the new target location.

[0093] To determine the proper skin entry site 406 based on a specified vessel entry site 405, the processor can calculate the distance L between the edge of the ultrasound sensor 403 and the skin entry site 406 using EQ 1. As noted, for exemplary purposes only, the distance between the edge of the ultrasound sensor 403 and the specific ultrasound generating site 407 can be, as shown in FIG. 4, about 4 mm.L = D * tan(q) -4 mm EQ 1

[0094] To complete the example, if tan(q) is found to be 1.5, and the target vessel 402 is determined to be at a depth of 6 mm, the distance L from the edge of the ultrasound sensor 403 to the skin entry site 406 can be determined, by the processor, to be 5 mm. The processor can control the needle delivery device (not shown in FIG. 4) to insert the needle at angle q, and at a calculated point from the edge of the ultrasound sensor 403. Following the previous example, the calculated point from the edge of the ultrasound sensor 403 can be 5 mm. As described, the needle delivery device can be physically coupled to the ultrasound sensor 403, precisely controlling the angle q and distance L for proper insertion into the target vessel 402. One of skill in the art will understand that the system can calculate the proper skin entry site for any given angle q, ultrasound sensor size, and depth of the target vessel. The system can then adjust the needle angle and lateral distance (L) to optimize the needle approach angle. The system then calculates a desired needle insertion speed and either inserts the needle or receives instructions from a user-controlled controller to insert the needle.

[0095] As described, the desired needle insertion speed can be based on the comfort of the user. In some embodiments, the system 100 can adjust the needle 101, 302, 404 insertion speed based on data from the ultrasound sensors 104, 105, 106, 303, 403. For example, the ultrasound sensors 104, 105, 106, 303, 403 can detect tissue deflection due to movement of tissue caused by needle insertion. A needle 101, 302, 404 insertion speed that is too slow may cause pushing of the tissue. If pushing is an issue with a particular needle 101, 302, 404 insertion speed, the system can increase the needle 101, 302, 404 insertion speed to result in a better puncture. In some embodiments, additional sensors can be included to measure the force encountered by the needle 101, 302, 404 as the needle is inserted. A high force can indicate that the needle 101, 302, 404 is being inserted too slowly, which can cause discomfort for the user.

[0096] In some embodiments, the system 100 can be set to use a button-hole technique, using the same access site each insertion of a needle. In some embodiments, the system can use a rope and ladder technique, adjusting the access site in the target vessel using multiple locations. The system can, in some embodiments, be set to use different access points for each insertion within the same access fistula or graft.

[0097] Because the ultrasound sensors 104, 105, 106, 303, 403 described can provide imaging of the needle and the entire target vessel, the same ultrasound sensors 104, 105, 106, 303, 403 used for placement of the needle can be used to determine whether the needle was advanced too far into the target vessel, thus penetrating the vessel on the far side. The ultrasound sensors 104, 105, 106, 303, 403 can also be used to identity whether the needle is penetrating around the middle of the blood vessel, to prevent side wall injuries. The ultrasound sensors 104, 105, 106, 303, 403 can enable viewing of the entire circumference of the blood vessel, allowing the guidance system to cause penetration at a precise target position within the blood vessel. The ultrasound sensors 104, 105, 106, 303, 403 can also be used to identify previous unhealed or healing insertion locations so a different location could be chosen. The ultrasound sensors 104, 105, 106, 303, 403 can also be used to assess flow through the vessel to identify good vs bad target needle locations. In some embodiments, the sensors 104, 105, 106, 303, 403 can be a type of sensor that emits various types of electromagnetic radiation. For example, the sensors 104, 105, 106, 303, 403 can emit visual light, infrared light, x-ray, or some alternative electromagnetic radiation.

[0098] In some embodiments, additional sensors, such as an impedance sensor at the needle tip, additional ultrasound sensors 104, 105, 106, 303, 403, a temperature sensor, and / or a flow sensor on the needle can be included to ensure the needle is advanced into the target vessel and not through the vessel. These additional sensors can be in communication with the processor to ensure that the needle is inserted to a proper depth. The same additional sensors can be used to determine if the needle is successful in getting blood to flow out of the fistula or graft. A skin temperature sensor can be included to sense skin temperature around the fistula to record fistula health. In some embodiments, the system can include a camera to take a picture of the fistula before and after cannulation. With a camera, the processor can use previous images of the fistula to register the vasculature with the needle delivery device to guide placement of the needle deliverydevice for optimal needle delivery. The data can be stored and used for future cannulation location determination.

[0099] One skilled in the art will understand that various combinations and / or modifications and variations can be made in the described systems and methods depending upon the specific needs for operation. Various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. Moreover, features illustrated or described as being part of an aspect of the disclosure may be used in the aspect of the disclosure, either alone or in combination, or follow a preferred arrangement of one or more of the described elements. Depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., certain described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as performed by a single module or unit for purposes of clarity, the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

Claims

WHAT IS CLAIMED IS:

1. An autocannulation system, comprising: a needle delivery device connectable to at least one cannulation needle; at least one ultrasound sensor; a processor in communication with the at least one ultrasound sensor; wherein the processor is configured to 1) determine a target vessel location, a target vessel depth, and a target vessel orientation and 2) control delivery of the cannulation needle based on data from the at least one ultrasound sensor.

2. The system of claim 1, wherein the at least one ultrasound sensor comprises an array of ultrasound sensors.

3. The system of claim 2, wherein the array of ultrasound sensors comprises ultrasound sensors at multiple angles.

4. The system of claim 3, further comprising 3-D accelerometers to determine an angle of each of the ultrasound sensors with respect to a patient skin.

5. The system of claim 3, wherein an angle of each ultrasound sensor is adjustable.

6. The system of claim 5, further comprising 3-D accelerometers to control an angle of each of the ultrasound sensors with respect to a patient skin.

7. The system of claim 1, the needle delivery device connectable to at least two cannulation needles.

8. The system of claim 1, wherein the needle delivery device comprises a motor; and wherein the processor is programmed to control the motor to advance the cannulation needle into a target position within the target vessel.

9. The system of claim 1, further comprising a depth sensor in communication with the processor; the processor programmed to, after delivery of the cannulation needle, determine whether the cannulation needle was delivered to a proper depth.

10. The system of claim 9, wherein the depth sensor comprises an impedance sensor, an ultrasound sensor, a temperature sensor, a flow sensor, or combination thereof.

11. The system of claim 1, further comprising a skin temperature sensor in communication with the processor; the processor programmed to determine a fistula health based on the skin temperature sensor.

12. The system of claim 1, further comprising a camera to take a picture of a fistula before and after cannulation.

13. The system of claim 1, the processor further programmed to determine a flow through the target vessel and to determine a target position based on the flow through the target vessel.

14. The system of claim 8, further comprising a controller in communication with the processor; wherein the processor is programmed to control the motor to advance the cannulation needle based on the controller.

15. The system of claim 1, the processor further programmed to determine a needle location within the target vessel.

16. The system of claim 1, the processor further programmed to determine a needle insertion angle and / or needle insertion speed.

17. A method performed by an autocannulation system, comprising: receiving data from at least one ultrasound sensor; determining a target vessel location, a target vessel depth, and a target vessel orientation based on the data from the at least one ultrasound sensor; and controlling delivery of a cannulation needle loaded in a needle delivery device based on data from the at least one ultrasound sensor.

18. The method of claim 17, wherein the at least one ultrasound sensor comprises an array of ultrasound sensors.

19. The method of claim 18, wherein the sensor array comprises ultrasound sensors at multiple angles.

20. The method of claim 19, further comprising determining an angle of each of the ultrasound sensors with respect to a patient skin using one or more 3D accelerometers.

21. The method of claim 19, wherein an angle of each ultrasound sensor is adjustable.

22. The method of claim 21, further comprising controlling an angle of each of the ultrasound sensors with respect to a patient skin using one or more 3D accelerometers.

23. The method of claim 17, further comprising controlling delivery of a second cannulation needle loaded in the needle delivery device.

24. The method of claim 17, further comprising determining whether the cannulation needle was inserted to a proper depth using a depth sensor.

25. The method of claim 24, wherein the depth sensor comprises an impedance sensor, an ultrasound sensor, a temperature sensor, a flow sensor, or combination thereof.

26. The method of claim 17, further comprising determining a fistula health based on a skin temperature sensor.

27. The method of claim 17, further comprising determining a flow through the target vessel and determining a target needle location based on the flow through the target vessel.

28. The method of claim 17, further comprising determining a needle location within the target vessel.

29. The method of claim 17, further comprising determining a needle insertion angle and / or needle insertion speed.