System for automated cannula insertion in hemodialysis

Abstract

A system, components, and method are provided for delivering one or more cannula insertion needles into a blood vessel. The system, components, and method use a needle delivery device coupled to one or more ultrasonic sensors to control the delivery of the cannula insertion needles.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 527,308, titled "SYSTEM FOR HEMODIALYSIS AUTOCANNULATION," filed on July 17, 2023, the entire content of which is incorporated herein by reference.

[0002] (Field of the Invention) Systems, components, and methods are provided for delivering one or more cannula insertion needles into a blood vessel. The systems, components, and methods use a needle delivery device coupled to one or more ultrasonic sensors to control the delivery of the cannula insertion needle.

Background Art

[0003] Hemodialysis treatment requires that a patient have vascular access, i.e., an accessible entry site to the bloodstream. Options for long - term access include arteriovenous (AV) grafts or AV fistulas. The success of access cannula insertion is important for effective hemodialysis treatment. However, an increasing number of patients have difficult AV fistula cannula insertions or may be performing dialysis at home and thus need to perform self - cannulation. Inappropriate cannula insertion into the vascular access can cause infiltration, hematoma formation, infection, and aneurysms. These problems can lead to morbidity, hospitalization, access revision, and even loss of access. Thus, systems and methods for reducing the burden of cannula insertion are needed. To ensure patient safety and comfort, there is a further need for a system that can accurately insert a cannula insertion needle. This need extends to an automated cannula insertion system that uses sensors to ensure proper delivery and placement of the cannula insertion needle for each insertion.

Summary of the Invention

[0004] The challenge to be addressed is to accurately and safely deliver the cannula insertion needle into the patient's fistula. The solution involves using one or more ultrasonic sensors that communicate with a processor to control the delivery of the cannula insertion needle.

[0005] The first aspect relates to a system. The system comprises a needle delivery device connectable to at least one cannula insertion needle, at least one ultrasonic sensor, and a processor communicating with at least one ultrasonic sensor, wherein the processor is programmed to determine the location, depth, and orientation of a target vessel, and the processor is programmed to control the delivery of the cannula insertion needle based on data from at least one ultrasonic sensor.

[0006] In some embodiments, at least one ultrasonic sensor may include an array of ultrasonic sensors.

[0007] In some embodiments, an array of ultrasonic sensors may include ultrasonic sensors at multiple angles.

[0008] In some embodiments, the system may include a 3D accelerometer to determine the angle of each ultrasonic sensor relative to the patient's skin.

[0009] In some embodiments, the angle of each ultrasonic sensor can be made adjustable.

[0010] In some embodiments, the system may include a 3D accelerometer to control the angle of each ultrasonic sensor relative to the patient's skin.

[0011] In some embodiments, the needle delivery device can be connected to at least two cannula insertion needles.

[0012] In some embodiments, the needle delivery device may include a motor, and a processor may be programmed to control the motor to advance the cannula insertion needle to a target position within the target vessel.

[0013] In some embodiments, the system may include a depth sensor that communicates with a processor, which is programmed to determine, after delivery, whether the cannula insertion needle has been delivered to the appropriate depth.

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

[0015] In some embodiments, the system may include a skin temperature sensor that communicates with a processor. The processor is programmed to determine the health status of the fistula based on the skin temperature sensor.

[0016] In some embodiments, the system may include a camera for taking photographs of the fistula before and after cannula insertion.

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

[0018] In some embodiments, the system may include a controller that communicates with a processor. The processor is programmed to control a motor to advance the cannula insertion needle based on the controller.

[0019] In some embodiments, the processor may be programmed to determine the location of the needle within the target blood vessel.

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

[0021] Features disclosed as part of the first aspect can exist alone or in combination in the first aspect, or can follow any arrangement or permutation of any one or more of the described elements. Similarly, any feature disclosed as part of the first aspect can exist alone or in combination in the second aspect described below, or can 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 ultrasonic sensor, determining the location, depth, and orientation of a target blood vessel based on the data from the at least one ultrasonic sensor, and controlling the delivery of a cannula insertion needle loaded within a needle delivery device based on the data from the at least one ultrasonic sensor.

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

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

[0025] In some embodiments, the method can include using one or more 3D accelerometers to determine the angle of each ultrasonic sensor relative to the patient's skin.

[0026] In some embodiments, the angle of each ultrasonic sensor can be adjustable.

[0027] In some embodiments, the method can include using one or more 3D accelerometers to control the angle of each ultrasonic sensor relative to the patient's skin.

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

[0029] In some embodiments, the method can include using a depth sensor to determine whether the cannula insertion needle has been inserted to an appropriate depth.

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

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

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

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

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

[0035] Features disclosed as part of the second aspect can exist in the second aspect alone, or in combination, or can follow any arrangement or permutation of any one or more of the elements described. Similarly, features disclosed as part of the second aspect can exist in the first aspect alone, or in combination, or can follow any arrangement or permutation of any one or more of the elements described.

Brief Description of the Drawings

[0036] [Figure 1] Shows controlling the delivery of a cannula insertion needle according to some embodiments. [Figure 2] The images shown are of target blood vessels according to one embodiment, as well as several other embodiments. [Figure 3A] The orientation of the sensor relative to the target blood vessel is shown in several embodiments. [Figure 3B] The orientation of the sensor relative to the target blood vessel is shown in several embodiments. [Figure 4] The use of a cannula insertion needle in several embodiments is shown. [Modes for carrying out the invention]

[0037] Unless otherwise defined, all technical and scientific terms used have the same meaning as those generally understood by those skilled in the art.

[0038] The articles "a" and "an" are used to refer to one to more than one (i.e., at least one) of the grammatical objects of the article. For example, "a certain element" means one element or more than one element.

[0039] A "3D accelerometer" is a sensor that can detect motion along three mutually perpendicular axes.

[0040] The term "adjustable" refers to a system variable or state that can be changed.

[0041] The term "advancing" refers to the movement of the needle towards a target location within a blood vessel, either inside the patient's body or outside the patient's body toward the patient's skin, when referring to needle delivery.

[0042] The term "angle" refers to the relative direction of two components or lines.

[0043] A sensor "array" is a set of two or more sensors.

[0044] An "automated cannula insertion system" is a set of components that use an automated process to deliver a cannula insertion needle into a patient's blood vessel.

[0045] The term "camera" refers to a device that can acquire optical images of a system.

[0046] A "cannula insertion needle" is a thin, hollow tube that allows access to the blood in a patient's blood vessels.

[0047] The terms "communication" or "to communicate" refer to the ability to transfer electronic information, either via a wired connector or wirelessly.

[0048] The term "to prepare" includes, but is not limited to, anything that follows the word "to prepare." The use of this term indicates that the listed elements are necessary or essential, while the other elements are optional and may be present.

[0049] The terms “connected,” “connected,” “to connect,” or “connectable” refer to the ability to form physical contact between two components or parts. The connection does not have to be permanent.

[0050] The term "consists of" includes and is limited to anything that follows the phrase "consists of." This phrase indicates that the specified elements are necessary or essential, and that other elements cannot be present.

[0051] The term “essentially derived from” includes anything that follows the term “essentially derived from” and includes any additional elements, structures, actions, or features that do not affect the basic operation of the described apparatus, structure, or method.

[0052] The terms “to control,” “to control,” or “control” can refer to the ability of one component to direct the actions of a second component.

[0053] A "controller" is a device that monitors and influences the operating conditions of a given system. These operating conditions are typically referred to as the system's output variables, which can be influenced by adjusting specific input variables.

[0054] The term "delivery," when referring to a needle, means the insertion of a needle into a patient's body.

[0055] The term "depth" refers to the distance from the surface or from components within a blood vessel.

[0056] A "depth sensor" refers to a sensor capable of determining the distance to components below the surface or inside blood vessels.

[0057] The terms "to determine" or "to make a determination" refer to checking the state of a system, component, or object.

[0058] The term "fistula health" refers to the physiological health of the fistula within the patient's body.

[0059] The term "flow" refers to the movement of a fluid or gas.

[0060] A "flow sensor" is a sensor capable of determining the velocity or volume of a fluid moving through a conduit or system.

[0061] An "impedance sensor" is a sensor capable of determining the electrical impedance of a material.

[0062] A "motor" is a device or component that supplies power to a system.

[0063] A "needle delivery device" is a set of components that insert a needle into a patient's skin.

[0064] The term "needle insertion angle" refers to the angle formed between the needle shaft and the patient's skin.

[0065] The term "needle insertion speed" refers to the speed at which the needle moves while it is being inserted into the patient.

[0066] The term "location of the needle" refers to the actual physical location of the needle.

[0067] The term "patient's skin" refers to the external parts of the patient's body.

[0068] The term “processor” refers to any programmable or configurable logic circuit that can be configured to execute a desired algorithm. A processor can provide a generalized instruction set, as in the case of a microprocessor or microcontroller, or it can be configured in hardware, as in the case of an application-specific integrated circuit (FPGA). In some cases, a processor can be emulated and / or virtualized. For example, virtualization technology can provide a virtual processor that operates under a hypervisor or other type of virtualization layer, in which case the “processor” can include an emulation layer and a physical processor that ultimately executes the instructions.

[0069] The terms "programmable" or "programmed" refer to an electronic system that can receive instructions to perform a specified action.

[0070] The term "receive" data refers to obtaining data from any source by any means.

[0071] The term "target vessel" refers to the blood vessel into which the cannula insertion needle is inserted.

[0072] "Target vessel depth" is the distance between the outer layer of the patient's skin and the designated target vessel.

[0073] The "target location" is the specific spot within the target blood vessel where the needle will be inserted.

[0074] "Location of the target vessel" refers to the location of the target vessel within the patient's body.

[0075] "Target vessel orientation" refers to the direction in which the target vessel extends.

[0076] A "temperature sensor" is a sensor capable of determining the temperature of a material.

[0077] An "ultrasonic sensor" is a sensor that can detect sound waves of a specified frequency.

[0078] Automated cannula insertion system Figure 1 shows the use of the automated cannula insertion system 100 in several embodiments. As illustrated in Figure 1, the cannula insertion needle 101 can be inserted through the patient's skin 103, allowing the tip 102 of the cannula insertion needle 101 to be positioned within a target vessel (not shown). The system may include one or more ultrasonic sensors, such as ultrasonic sensor 104, ultrasonic sensor 105, and ultrasonic sensor 106. As shown in Figure 1, multiple ultrasonic sensors may be arranged in a sensor array. In some embodiments, a single ultrasonic sensor may be used. Those skilled in the art will understand that any number of ultrasonic sensors, including 1, 2, 3, 4, 5, or more ultrasonic sensors, may be used. In some embodiments, at least one ultrasonic sensor 104, 105 may be used. In some embodiments, multiple ultrasonic sensors 104, 105, 106 may be used. The ultrasonic sensors 104, 105, 106 may communicate with a processor (not shown) of the automated cannula insertion system 100. The processor may be programmed to receive data from ultrasonic sensors 104, 105, and / or 106 to determine the precise location of the tip 102 of the cannula insertion needle 101 and the target vessel. Although referred to as ultrasonic sensors 104, 105, and 106, it should be understood that sensors 104, 105, and 106 may be any type of electromagnetic sensor capable of emitting electromagnetic waves or energy.

[0079] In certain embodiments, the processor may be connected to a display (not shown). The display can show the user the precise location of the cannula insertion needle 101 as it enters the patient's skin 103. For example, the user can visualize the cannula insertion needle 101 moving through the patient's skin 103 toward the target vessel. The target vessel can also be imaged using one or more ultrasound sensors 104, 105, 106 to provide the user with a clear image of the insertion of the cannula insertion needle 101 into the target vessel.

[0080] The tip 102 of the cannula insertion needle 101 can be visualized using at least one of the ultrasonic sensors 104, 105, and 106. The echo of the tip 102 of the cannula insertion needle 101 can be visualized by diffraction of ultrasound, which can scatter a uniform wave with relatively low amplitude in different directions. The shaft of the cannula insertion needle 101 can be visualized by reflection, as the shaft of the cannula insertion needle 101 is larger than the wavelength of the ultrasound, producing an acoustic shadow 107. According to the law of reflection, the shaft echo is maximized when the ultrasound strikes the cannula insertion needle 101 at an angle close to 90°, which allows for visualization of the shaft even in highly echogenic subcutaneous tissue. Therefore, the angle between ultrasonic sensors 104, 105, and 106 and the cannula insertion needle 101, shown as angle 108 in Figure 1, can be maintained at or close to 90°. However, reflection from the shaft of the cannula insertion needle 101 can be used at other lower angles. In some embodiments, different angles can be used for each sensor in the ultrasound array, allowing visualization of the cannula insertion needle 101 and the target vessel from multiple angles. In some embodiments, the angles of the ultrasound sensors may be adjustable. The processor can determine the angle of each ultrasound sensor by any means known in the art. For example, a 3D accelerometer can be used to determine the angle of each ultrasound sensor. The angle of each ultrasound sensor relative to the patient's skin can thus be precisely controlled. In some embodiments, the cannula insertion needle 101 may have an echogenic coating to improve the visibility of the needle.

[0081] A needle delivery device (not shown in Figure 1) can position the cannula insertion needle 101 within a target vessel. The needle delivery device may include a motor to move the cannula insertion needle 101 into the target vessel and adjust the delivery angle and entry point. A processor receiving data from an ultrasonic sensor can determine the precise location of the cannula insertion needle 101 and the target vessel to control delivery. The processor may be programmed to determine an appropriate needle insertion angle and / or needle insertion speed to accurately and safely position the cannula insertion needle 101 within the target vessel. For example, the processor can influence patient outcomes by improving the accuracy of cannula insertion needle 101 placement. In some embodiments, the system may include a controller for the needle delivery device. For example, a user can visualize the placement of the needle and target vessel and use the controller to precisely deploy the device. In some embodiments, the automated cannula insertion system 100 may be connected to an external display to assist in the placement of the cannula insertion needle 101. In some embodiments, an app, joystick, or other component may be used as a controller by the user. In some embodiments, needle deployment can be automated using a processor programmed to receive data from an ultrasonic sensor and precisely position the cannula insertion needle 101. In some embodiments, the needle insertion speed can be set to a speed that is comfortable for the patient. For example, the needle insertion speed can be set to a speed equivalent to that of normal manual insertion of the cannula insertion needle 101. In some embodiments, the system can use a faster or slower speed depending on user comfort. In some embodiments, the insertion speed can be adjusted by the user, the patient, or a combination thereof.

[0082] In some embodiments, the ultrasonic sensors 104, 105, and 106 can be physically coupled to the needle delivery device. For example, an armband or other device may be used to couple the needle delivery device with the ultrasonic sensors 104, 105, and 106. Physically coupling the needle delivery device with the ultrasonic sensors 104, 105, and 106 allows the processor to determine the distance of the needle tip to at least one of the sensor array, the blood vessel in which the sensors are located, and the angle of the needle approach. The needle delivery device may include one or more cannula insertion needles. For example, the needle delivery device may be loaded with two cannula insertion needles, allowing for the arrangement of multiple needles. In some embodiments, the two needles can be oriented in a retrograde position, in which case they are inserted into the target blood vessel in opposite directions. In some embodiments, the needles can be oriented in an antegrade position, in which case both needles are inserted into the target blood vessel in the same direction.

[0083] Figure 2 illustrates the use of ultrasonic sensors 104, 105, and 106 to facilitate visualization of the target vessel 205. A transducer 201 having ultrasonic sensors 104, 105, and 106 or an array of ultrasonic sensors may be placed on the patient's skin 202. Ultrasound can penetrate the epidermis 203 and dermis 204 to reach the target vessel 205. Some of the ultrasound is reflected by the anterior wall 206 and posterior wall 207 of the target vessel 205. The ultrasonic sensors on transducer 201 can detect the reflections from the anterior wall 206 and posterior wall 207 of the target vessel 205 to determine the precise depth, orientation, and location of the target vessel 205, thereby assisting in the placement of the cannula insertion needle. Using the data from the ultrasonic sensors, the system's processor can determine the location, depth, orientation, etc., of the target vessel to determine the target location of the cannula insertion needle 101. Images acquired by ultrasonic sensors 104, 105, and 106 are processed through artificial intelligence ("AI") or standard image processing software known in the art to identify the underlying target vessels 205. In some embodiments, the delivery system may be directed to or guided by markers on the patient, including tattoos, birthmarks, scars, and markers embedded on the implanted AV graft, to assist in needle placement. As shown in Figure 2, the ultrasonic sensor array may be manufactured using wafer-based manufacturing techniques on a flexible transducer substrate that can be reused or discarded after a single use.

[0084] Figures 3A and 3B illustrate the use of an ultrasonic sensor to position the cannula insertion needle 302. In both Figures 3A and 3B, the system can use the ultrasonic sensor 303 to determine the location of the cannula insertion needle 302 and the target vessel 301. In Figure 3A, the ultrasonic sensor 303 is oriented laterally to the cannula insertion needle 302, in which case the beam 304a is perpendicular to the target vessel 301. In contrast, Figure 3B illustrates the ultrasonic sensor 303 oriented longitudinally to the cannula insertion needle 302, in which case the beam 304b is parallel to the target vessel 301.

[0085] Using the lateral orientation illustrated in Figure 3A, the user can view the entire circumference of the target vessel 301. Viewing the entire circumference of the target vessel 301 is useful for positioning the cannula insertion needle 302 in small vessels such as small veins, by allowing the user to directly enter the target vessel 301 on top of it. By dynamically scanning the target vessel 301 using the coordinated advancement of the cannula insertion needle 302, highly accurate cannula insertion is possible.

[0086] In some embodiments, a 2D array of ultrasonic sensors may be used. The 2D array of ultrasonic sensors may be positioned in either a lateral or vertical orientation. By using a 2D array of ultrasonic sensors, visualization of the cannula insertion needle during insertion can be improved.

[0087] Figure 4 illustrates the use of the automated cannula insertion system 100. An ultrasonic sensor 403 is positioned on the patient's skin 401 above the target vessel 402. In some embodiments, the system may be guided by markers on the patient, including tattoos, birthmarks, scars, and markers embedded on the implanted AV graft, to determine the approximate location of the target vessel 402 and / or its location within the vessel for insertion. The cannula insertion needle 404 may then be inserted into the target vessel 402, guided by data from one or more ultrasonic sensors 403.

[0088] The skin entry site 406 can be determined by the system's processor (not shown). The skin entry site 406 is based on the depth of the target position within the target vessel 402, indicated as depth D in Figure 4, and the angle of the cannula insertion needle 404 relative to the skin 401, indicated as angle q in Figure 4. Generally, the target position is the center of the target vessel 402 and the angle is as close as possible to parallel with the direction of the target vessel 402. The distance between the edge of the ultrasonic sensor 403 and a specific ultrasonic generating site 407 may vary between probes. In some embodiments, the distance between the edge of the ultrasonic sensor 403 and a specific ultrasonic generating site 407 may be about 3 mm to about 5 mm. In some embodiments, this distance may be about 4 mm, as shown in Figure 4. The system may determine this distance during calibration or receive it by other means.

[0089] In some embodiments, the system 100 can incorporate data from previous cannula insertions to select a target insertion site. For example, previous images collected by the system, which may include ultrasound images from previous cannula insertions or any other imaging, as well as previous insertion sites, previous target vessel locations, and resulting flow or dialysis results from previous target locations, may be input to or stored by the system. In some embodiments, this information may be used as input for automatically selecting a new target location.

[0090] To determine an appropriate skin entry site 406 based on a specific vascular entry site 405, the processor can calculate the distance L between the edge of the ultrasonic sensor 403 and the skin entry site 406 using Equation 1. As described above, for illustrative purposes only, the distance between the edge of the ultrasonic sensor 403 and a specific ultrasonic generating site 407 may be approximately 4 mm, as shown in Figure 4. L=D * tan(q)-4mm equation 1

[0091] To complete this 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 ultrasonic sensor 403 to the skin entry site 406 may be determined by the processor to be 5 mm. The processor can control the needle delivery device (not shown in Figure 4) to insert the needle at an angle q and at the point calculated from the edge of the ultrasonic sensor 403. Following the previous example, the calculated point from the edge of the ultrasonic sensor 403 may be 5 mm. As described, the needle delivery device is physically coupled to the ultrasonic sensor 403 and can precisely control the angle q and distance L for proper insertion into the target vessel 402. Those skilled in the art will understand that the system can calculate a suitable skin entry site for any given angle q, ultrasonic sensor size, and target vessel depth. 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 inserts the needle or receives a command from a user control controller to insert the needle.

[0092] As described, the desired needle insertion speed can be based on user comfort. In some embodiments, the system 100 can adjust the insertion speed of needles 101, 302, and 404 based on data from ultrasonic sensors 104, 105, 106, 303, and 403. For example, ultrasonic sensors 104, 105, 106, 303, and 403 can detect tissue deflection caused by tissue movement during needle insertion. Inserting needles 101, 302, and 404 too slowly can cause tissue pushing. If pushing is a problem with respect to a particular needle insertion speed of 101, 302, and 404, the system can increase the insertion speed of needles 101, 302, and 404 to result in a better puncture. In some embodiments, additional sensors can be included to measure the force that needles 101, 302, and 404 experience when they are inserted. High force may indicate that needles 101, 302, and 404 are being inserted too slowly, which can cause discomfort to the user.

[0093] In some embodiments, the system 100 can be configured to use the buttonhole technique, using the same access site for each needle insertion. In some embodiments, the system can use rope and ladder techniques and multiple locations to adjust the access site within the target vessel. In some embodiments, the system can be configured to use different access points for each insertion within the same access fistula or graft.

[0094] The described ultrasonic sensors 104, 105, 106, 303, and 403 can provide imaging of the needle and the entire target vessel, so the same ultrasonic sensors 104, 105, 106, 303, and 403 used for needle placement can be used to determine whether the needle has advanced too far into the target vessel and therefore penetrated the vessel on the far side. The ultrasonic sensors 104, 105, 106, 303, and 403 can also be used to identify whether the needle has penetrated around the center of the vessel to prevent damage to the sidewall. The ultrasonic sensors 104, 105, 106, 303, and 403 can enable visualization of the entire circumference of the vessel, allowing the guidance system to cause penetration at a precise target location within the vessel. The ultrasonic sensors 104, 105, 106, 303, and 403 can also be used to identify previous unhealed or healed insertion sites, so that different locations can be selected. Ultrasonic sensors 104, 105, 106, 303, and 403 can also be used to evaluate blood flow through blood vessels to identify good and bad target needle locations. In some embodiments, sensors 104, 105, 106, 303, and 403 may be sensors that emit various types of electromagnetic radiation. For example, sensors 104, 105, 106, 303, and 403 may emit visible light, infrared light, X-rays, or some alternative electromagnetic radiation.

[0095] In some embodiments, additional sensors may be included, such as an impedance sensor at the needle tip, additional ultrasonic sensors 104, 105, 106, 303, 403, a temperature sensor, and / or a flow sensor on the needle, to ensure that the needle advances into the target vessel and does not penetrate the vessel. These additional sensors can communicate with the processor to ensure that the needle is inserted to the appropriate depth. The same additional sensors can be used to determine whether the needle has successfully drained blood from the fistula or graft. A skin temperature sensor may be included to sense the skin temperature around the fistula to record the health of the fistula. In some embodiments, the system may include a camera to take pictures of the fistula before and after cannula insertion. Using the camera, the processor can use previous images of the fistula to align the vascular system with the needle delivery device and guide the placement of the needle delivery device for optimal needle delivery. The data can be stored and used for future cannula insertion location determination.

[0096] Those skilled in the art will understand that various combinations and / or modifications and variations may be made in the described systems and methods depending on the specific needs for operation. The various embodiments disclosed herein may be combined in combinations different from those specifically presented in the description and accompanying drawings. Furthermore, features illustrated or described as part of an embodiment of this disclosure may be used individually or in combination in embodiments of this disclosure, or in accordance with a preferred configuration of one or more of the described elements. By example, some actions or events of any process or method described herein may be performed in different sequences, added, merged, or completely excluded (for example, certain described actions or events may not be necessary to perform the technique). In addition, while certain embodiments of this disclosure are described for clarity as being performed by a single module or unit, the techniques of this disclosure may be performed, for example, by a combination of units or modules associated with a medical device.

Claims

1. An automated cannula insertion system, A needle delivery device that can be connected to at least one cannula insertion needle, At least one ultrasonic sensor, A processor that communicates with at least one ultrasonic sensor, The system is configured such that the processor 1) determines the location, depth, and orientation of the target vessel, and 2) controls the delivery of the cannula insertion needle based on data from the at least one ultrasonic sensor.

2. The system according to claim 1, wherein the at least one ultrasonic sensor includes an array of ultrasonic sensors.

3. The system according to claim 2, wherein the array of ultrasonic sensors includes ultrasonic sensors at multiple angles.

4. The system according to claim 3, further comprising a 3D accelerometer for determining the angle of each of the ultrasonic sensors relative to the patient's skin.

5. The system according to claim 3, wherein the angle of each ultrasonic sensor is adjustable.

6. The system according to claim 5, further comprising a 3D accelerometer for controlling each angle of the ultrasonic sensor relative to the patient's skin.

7. The system according to claim 1, wherein the needle delivery device is connectable to at least two cannula insertion needles.

8. The needle delivery device includes a motor, The system according to claim 1, wherein the processor is programmed to control the motor to advance the cannula insertion needle to a target position within the target blood vessel.

9. The system further includes a depth sensor that communicates with the aforementioned processor, The system according to claim 1, wherein the processor is programmed to determine, after the delivery of the cannula insertion needle, whether the cannula insertion needle has been delivered to an appropriate depth.

10. The system according to claim 9, wherein the depth sensor includes an impedance sensor, an ultrasonic sensor, a temperature sensor, a flow sensor, or a combination thereof.

11. The system further comprises a skin temperature sensor that communicates with the aforementioned processor, The system according to claim 1, wherein the processor is programmed to determine the health status of the fistula based on the skin temperature sensor.

12. The system according to claim 1, further comprising a camera for taking photographs of the fistula before and after cannula insertion.

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

14. The system further comprises a controller that communicates with the aforementioned processor, The system according to claim 8, wherein the processor is programmed to control the motor to advance the cannula insertion needle based on the controller.

15. The system according to claim 1, wherein the processor is further programmed to determine the location of the needle within the target blood vessel.

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

17. A method performed by an automated cannula insertion system, Receiving data from at least one ultrasonic sensor, Based on the data from the at least one ultrasonic sensor, the location of the target vessel, the depth of the target vessel, and the orientation of the target vessel are determined. A method comprising controlling the delivery of a cannula insertion needle loaded in a needle delivery device based on data from at least one ultrasonic sensor.

18. The method according to claim 17, wherein the at least one ultrasonic sensor includes an array of ultrasonic sensors.

19. The method according to claim 18, wherein the sensor array includes ultrasonic sensors at multiple angles.

20. The method according to claim 19, further comprising using one or more 3D accelerometers to determine the angle of each of the ultrasonic sensors relative to the patient's skin.

21. The method according to claim 19, wherein the angle of each ultrasonic sensor is adjustable.

22. The method according to claim 21, further comprising using one or more 3D accelerometers to control the angle of each of the ultrasonic sensors relative to the patient's skin.

23. The method according to claim 17, further comprising controlling the delivery of a second cannula insertion needle loaded in the needle delivery device.

24. The method according to claim 17, further comprising using a depth sensor to determine whether the cannula insertion needle has been inserted to an appropriate depth.

25. The method according to claim 24, wherein the depth sensor includes an impedance sensor, an ultrasonic sensor, a temperature sensor, a flow sensor, or a combination thereof.

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

27. To determine the flow through the aforementioned target vessel, The method according to claim 17, further comprising determining the location of a target needle based on the flow through the target vessel.

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

29. The method according to claim 17, further comprising determining the needle insertion angle and / or needle insertion speed.

Images