Vascular access devices and methods

Abstract

The present disclosure relates to implantable vascular access devices. The disclosure further relates to methods and kits including such vascular access devices, as well as delivery systems for delivering such devices to appropriate implantation sites. The disclosure also relates to methods for implanting such devices and methods for locating such devices once implanted.

Description

[Technical Field]

[0001] This disclosure claims the benefit of European Patent Application EP22382775.9, filed August 10, 2022.

[0002] The present disclosure relates to implantable medical devices, and more particularly to implantable vascular access devices. The present disclosure further relates to methods for locating and accessing implanted vascular access devices, and methods for implanting and positioning such devices. [Background technology]

[0003] Vascular access systems are known to be used to provide repeated access to a patient's body during treatment or for diagnostic purposes. For example, the use of such implants is known in oncology treatments. The implant typically includes a port closed by a septum and a catheter connected to the port. The port may be implanted in the patient's chest in a "pocket" created under the patient's skin.

[0004] The catheter may be connected to a patient's jugular vein, subclavian vein, or other major vein that drains into a large vein (usually the superior vena cava). The needle may be used to inject a therapeutic substance, such as a chemotherapy agent, into the port and deliver it into the body. The needle may also be used to withdraw blood from shallow tissue areas within the patient's body, for example, subcutaneously, for diagnostic or analytical purposes.

[0005] Even though the port may be fairly small, depending on the patient's age and body type, the port may appear to protrude from the patient's chest.

[0006] An incision of, for example, about 2 cm or 2.5 cm is required to create a subcutaneous pocket for inserting the implant.

[0007] Medical professionals rely on palpation techniques to locate the port for injection. Even if the port is located, the septum that is punctured for access is not visible to the professional. A common technique is to hold the port to prevent movement during or before injection.

[0008] To improve the port location and access procedure, it is known to provide ports with multiple small protrusions. Recognizing these protrusions reduces errors during needle insertion. WO 2007 / 041471 provides multiple LEDs and light guides that provide multiple visual indicators around the port septum to aid in port access. The LEDs are illuminated by pressing on the port. Such devices have been commercialized but have been withdrawn from the market due to serious side effects related to device extrusion and infection.

[0009] DE 10 2015 122 061 discloses a port with multiple optical modules.

[0010] Complications from using different ports include extensive scarring, wound infection, and device extrusion. Another common complication is incorrect injection (injecting next to the port instead of into it), which can lead to pain and anxiety for the patient, an increased risk of catheter infection, and scarring, which can be particularly traumatic for pediatric patients.

[0011] If an access error goes undetected, medications can be injected outside the reservoir (subcutaneous tissue), potentially resulting in skin necrosis and the need for device removal and replacement, a serious consequence for highly irritating medications. Because the risk of infection increases with frequency of handling, access errors exponentially increase the risk of infection. Port infection is a serious complication (catheter sepsis) that often resists antibiotic treatment. In such cases, removal of the device may be necessary after a surgical procedure in an operating room, typically under local or general anesthesia. Pediatric surgery requires general anesthesia, which can increase patient anxiety. Furthermore, repeated general anesthesia increases the risk of neurological damage.

[0012] Furthermore, the use of a port can be uncomfortable and even traumatic for the patient due to aesthetic aspects, discomfort during sports, and normal activities (eg, wearing a seat belt in a car).

[0013] The present disclosure aims to provide a method and apparatus that avoids, or at least reduces, one or more of the above-mentioned disadvantages. Summary of the Invention

[0014] In one aspect of the present disclosure, an implantable vascular access device is provided, the device comprising: a housing; a reservoir having an outlet lumen; a septum for closing the reservoir and defining an injection area; a visualization system for visualizing the injection area; and a controller configured to operate the visualization system. The implantable vascular access device is self-dissecting.

[0015] In accordance with this aspect, a self-dissecting implantable vascular access device is provided. As used throughout this disclosure, self-dissecting may be understood to refer to a device shaped and sized such that it does not require specific dissection to create a space for implantation or positioning. While prior art ports require the creation of a pocket beneath the skin, typically beneath the subcutaneous fatty tissue, a vascular access device according to this aspect does not require such a pocket. The ability to be introduced beneath the subcutaneous tissue without the need for dissection is generally a combination of size and shape. In particular, the dimensions of the implantable vascular device may generally be smaller than prior art devices, and in embodiments, the exterior profile of the vascular access device may have a tapered portion. Along the tapered portion, the width and / or height may gradually increase to facilitate gradual introduction. Bumps, bumps, and protrusions may generally be avoided along the exterior surface, particularly along the tapered portion.

[0016] In embodiments, the vascular access device may be significantly smaller than previously known ports. Because the vascular access device according to this aspect is significantly smaller, it is generally not visible externally and is more comfortable for the patient. There are times when it is desirable to verify the location of the device, such as when giving an injection or drawing a blood sample, but the device is not easily palpated or visually inspected externally. In this regard, the vascular access device according to this aspect includes a visualization system and a controller that activates the visualization system to assist a professional (doctor, surgeon, nurse) in locating the device without the need for palpation.

[0017] According to a second aspect, an implantable vascular access device is provided, comprising a housing, a reservoir having an outlet lumen, a septum for closing the reservoir and defining an injection area, and one or more sensors arranged to measure one or more parameters of blood in the reservoir. The implantable vascular access device further comprises a transmitter for transmitting the measured parameters. In accordance with this aspect, an implantable vascular access device is provided that can be used to obtain measurements remotely. Because the implantable vascular access device is in direct communication with the patient's blood vessel, measurements can be made by the sensors and the resulting data can be transmitted. This eliminates or reduces the need for a professional to puncture the patient to obtain a sample for analysis. This may result in a less traumatic patient experience, especially for children.

[0018] In examples, the sensors may be configured to measure one or more of body temperature, heart rate, oxygen saturation, blood glucose, PCR sensor, pH, lactate, and the like.

[0019] The first and second aspects may be combined.

[0020] In some instances, the height of the device is less than 10 mm, specifically less than 8 mm, and more specifically less than 6 mm. Because there is no need to palpate the location, the device can be made as small as possible, specifically as "flat" as possible. In embodiments, the height of the device depends on the size of the catheter to be attached to the port, and the height of the device may simply be the height required to connect the catheter.

[0021] In some embodiments, the injection area is 75 mm 2 or 75mm 2 Ultra, specifically 85mm 2 or 85mm 2 Ultra, more specifically 95mm 2 or 95mm 2The size of the vascular access device may be greater than that of the prior art. While it is generally desirable to minimize the size of the vascular access device, the most important dimension in terms of patient comfort may be the height of the vascular access device. The injection area may actually be larger than in the prior art to make injections safer and / or the device more durable. The larger injection area also reduces repeated needle sticks and scarring.

[0022] In some embodiments, the width of the vascular device is 12 mm or less, specifically 10 mm or less, more specifically 8 mm or less, or 5 mm or less. A smaller width may result in a smaller injection area. The smallest width of a currently commercially available pediatric vascular access device is 19 mm. A 12 mm width allows for a skin incision of 10 mm or less. This dimension allows for tunneling with certain tunnelers and autodissection, as disclosed below.

[0023] A width of 8 mm or less is desirable to allow for a smaller skin incision and easier tunneling, while a width of 5 mm or less is an improvement, allowing the injection area to be maintained or expanded, for example, by increasing the length of the device.

[0024] Because devices according to embodiments of the present disclosure are generally unnoticeable under the skin due to their limited height and due to the visualization system, dimensions can vary. In particular, the length of the vascular access device can be increased to increase the size of the injection area without adversely affecting other performance features.

[0025] In some embodiments, the length of the vascular access device may be 30 mm or greater, specifically 35 mm or greater, more specifically 40 mm or greater, or even 50 mm or greater. In some embodiments, vascular access devices according to the present disclosure may be significantly longer than the prior art. The increased length of the vascular access device may be provided, inter alia, by a tapered section of significant length. The tapered section may have a taper height and / or a taper width.

[0026] In some embodiments, the visualization system may be configured to indicate the perimeter of the injection area. The visualization system may be positioned, for example, along the perimeter of the injection area. A nurse or other professional need only ensure that the perimeter is properly punctured. Injection errors and associated patient complications may be avoided or reduced.

[0027] In embodiments, the visualization system may be configured to indicate a puncture site within the injection area, i.e., provide instructions to the healthcare professional indicating where within the injection area the puncture should preferably be performed. The appropriate puncture site may be varied to avoid wear or deterioration of a particular portion of the septum.

[0028] In some embodiments, the visualization system comprises one or more light emitting devices arranged along the perimeter of the injection area. Suitable light emitting diodes can be used to transmit light when activated, which can be seen through the patient's skin. Multiple LEDs can be arranged along the perimeter of the injection area. In embodiments, the LEDs used can be millimeters in size (e.g., 1-3 mm in width or diameter). Multiple LEDs can be used to indicate the boundaries of the injection area. Alternatively, a ring-shaped LED can be used to indicate the perimeter of the injection area. Using multiple light emitting devices, such as LEDs, can also spread the needle penetration over the entire injection area.

[0029] In a further embodiment, the visualization system comprises an augmented reality device. The nurse (or other professional) may wear appropriate glasses with the augmented reality system. Upon activation of the visualization system, the location of the vascular access device (or in particular the injection area) may be projected onto the patient's skin, which may facilitate puncturing the septum of the device.

[0030] In embodiments, the device may further comprise an energy source, optionally a battery. In other embodiments, power / energy may be supplied remotely, for example upon activation by another device. For example, wireless power transmission may be used.

[0031] In some embodiments, the controller may be configured to activate the visualization system after receiving a command from a remote control. Such a remote control may be, for example, a PDA, tablet, smartphone, etc. When access to the device is required, the remote control may send a command to the controller to activate the visualization system. The visualization may be programmed in various ways, and may be programmed to illuminate the injection area (or its surroundings) for a predefined period of time, which may be, for example, one or two minutes, or any other time appropriate for the procedure to be completed. After the predetermined period of time, the visualization system may power down. In this way, power consumption may be appropriately reduced.

[0032] The same PDA, tablet or smartphone may be used to acquire measurement variables from sensors (if available).

[0033] In some embodiments, the exit lumen is located at a first end of the device, and the device may further include a device connector for releasably coupling to a connector of a delivery system. The vascular access device can be pulled or dragged toward the appropriate site.

[0034] In some embodiments, the device connector may be an eye or eyelet configured to receive a hook of the delivery system, hi other embodiments, the device connector is a connector for magnetically coupling to a connector of the delivery system.

[0035] In a further aspect, there is provided a system comprising a vascular access device according to any of the embodiments, and further comprising a data processing system having a receiver for receiving data transmitted by the transmitter of the device, and a database for storing the received data.

[0036] In an embodiment, such a system may further comprise a display for visualizing the received data. By way of example, the data processing system may be a personal computer, a tablet, a mobile phone, a smartphone, or a personal digital assistant. Other suitable data processing systems may also be used.

[0037] In embodiments, the data processing system not only receives data from the sensors for further processing or transmits data for further processing, but the data processing system may also be used to transmit instructions to the vascular access device, for example, instructions for measurements and / or instructions for operation of a visualization system may be transmitted from such a system.

[0038] In some embodiments, the data processing system may store the data for further processing and / or upload the data to a hospital or other website portal. The patient and / or other healthcare professionals can review the data as needed. In further embodiments, the data may be transmitted to a smartphone of the patient or the patient's guardian or representative. The user may download an appropriate application to review and visualize the data.

[0039] In yet another aspect, a kit is provided that includes an implantable vascular access device according to any of the embodiments disclosed herein and a remote control for sending one or more instructions to the control device of the implantable vascular access device.

[0040] The remote control may be a personal computer, tablet, mobile phone, smartphone, or personal digital assistant. Such a remote control may be used to send instructions, request measurement data if sensors are provided, activate the visualization system, etc. In some embodiments, the remote control may be built into the needle. The visualization system may be activated by proximity of the needle.

[0041] In yet another aspect, a method for locating a vascular access device implanted in a patient is provided, the method including remotely activating a visualization system of the vascular access device to visualize an area surrounding an injection region of the vascular access device, and detecting the area surrounding the injection region to locate the vascular access device while refraining from palpation of the patient.

[0042] In accordance with this aspect, vascular access devices and injection areas of such devices may be identified by a professional without palpation, which allows the vascular access devices to be generally smaller and particularly flatter than prior art devices.

[0043] In some embodiments, the vascular access device may be completely invisible from outside the patient when the visualization system is not activated. In some embodiments, the vascular access device is made substantially impossible to detect by palpation.

[0044] In yet another aspect, a delivery system is provided for delivering a vascular access device having a first end and a second end and an exit lumen having a device connector for coupling to a catheter disposed at the first end, the delivery system including a tunneler configured to provide a tunnel between the first access site and the second access site, wherein the tunneler is further configured to be releasably coupled to the vascular access device at the second end of the vascular access device.

[0045] In accordance with this aspect, a delivery system is provided that allows a vascular access device to be implanted at a suitable implantation site without the need to form a pocket. A delivery system is provided herein that is particularly suited for implanting vascular access devices, which generally have small dimensions. A subcutaneously formed tunnel can be occupied by a catheter attached to the vascular access device. Tissue growth can then occur around the catheter.

[0046] The first access site herein may be considered a venous access site. The second access site is equivalent to a device access site in the prior art. However, in embodiments of the present disclosure, such a classical device access site is not required.

[0047] Throughout this disclosure, tunneling may be understood as the creation of a subcutaneous passageway. A tunneler, also known as a "vascular tunneler" or "tunneler," is a device configured for tunneling. A tunneler generally has a tubular body and a "tunneling" tip, where the tip separates tissue to create the tunnel.

[0048] In embodiments, the tunneler may be configured to release the vascular access device at a location between the first access site and the second access site. The tunneler may be used to pull the vascular access device from the first access site to the second access site and release the vascular access device at the intended location.

[0049] The first access site may be at or near the vascular access point, i.e., the patient's neck or subclavian area. The second access site may be in the patient's armpit. Since no ports are created and only a small incision is required, minimal scarring is possible, allowing for less cosmetic considerations when selecting an appropriate access site.

[0050] In yet another aspect, a method of delivering a vascular access device to an implantation site is provided. The method includes providing a first access site through a patient's skin, introducing a catheter into a vein through the first access site, providing a second access site through the patient's skin, and providing a tunnel between the first and second access sites using a tunneler. The method further includes releasably coupling the tunneler to the vascular access device and moving the tunneler from the first access site toward the second access site to pull the vascular access device toward the second access site and releasing the vascular access device at the implantation site.

[0051] In some embodiments, creating a tunnel between the first and second access sites and pulling the vascular access device toward the second access site can occur simultaneously, i.e., a tunnel is formed from the first access site to the second access site while the vascular access device (with associated catheter) is dragged to the desired location.

[0052] In other embodiments, a tunnel may be provided from the second access site to the first access site using a tunneler, which may then be releasably coupled to a vascular access device (including a catheter), and the tunneler may be moved from the first access site to the second access site.

[0053] In embodiments, providing the second access site includes making an incision in the skin, where the incision may be less than 0.5 cm in length, specifically less than 3 mm in length, and more specifically 2 mm or less in length. Prior art systems and methods may require a relatively large incision at the second access site (proximal to the port implantation site) because a large port is introduced there and a pocket is formed. In embodiments of the present disclosure, the port may be significantly smaller, and only a tunneler may enter and exit the skin from the second access site, resulting in less scarring.

[0054] In some embodiments, the tunneler may be releasably mechanically coupled to the vascular access device, while in other embodiments, magnetic coupling or further alternatives may be used.

[0055] In some embodiments, the method may include visualizing the vascular access device and / or catheter while the vascular access device is being pulled from the first access site to the second access site. Optionally, the position of the catheter within the vein may be visualized by x-ray to confirm proper placement of the catheter.

[0056] Non-limiting examples of the present disclosure are described below with reference to the accompanying figures. [Brief explanation of the drawings]

[0057] [Figure 1A] FIG. 1A illustrates a schematic diagram of a first embodiment of a vascular access device according to the present disclosure. [Figure 1B] FIG. 1B illustrates a schematic diagram of a first embodiment of a vascular access device according to the present disclosure. [Figure 1C] FIG. 1C illustrates a schematic diagram of a first embodiment of a vascular access device according to the present disclosure. [Figure 1D] FIG. 1D illustrates a schematic diagram of a first embodiment of a vascular access device according to the present disclosure. [Figure 1E] FIG. 1E illustrates a schematic diagram of a first embodiment of a vascular access device according to the present disclosure. [Figure 2A] FIG. 2A shows a further embodiment of a vascular access device. [Figure 2B] FIG. 2B illustrates a further embodiment of a vascular access device. [Figure 2C] FIG. 2C illustrates a further embodiment of a vascular access device. [Figure 3A] FIG. 3A illustrates a schematic of an example of a delivery system for a vascular access device. [Figure 3B] FIG. 3B illustrates a schematic of an example of a delivery system for a vascular access device. [Figure 3C] FIG. 3C illustrates a schematic of an example of a delivery system for a vascular access device. [Figure 4A] FIG. 4A illustrates a schematic of one example of a method for implanting a vascular access device. [Figure 4B] FIG. 4B illustrates a schematic of one example of a method for implanting a vascular access device. [Figure 4C] FIG. 4C illustrates another embodiment of a method for implanting a vascular device. [Figure 5A] FIG. 5A schematically illustrates a further embodiment of a vascular access device. [Figure 5B] FIG. 5B schematically illustrates a further embodiment of a vascular access device. [Figure 5C] FIG. 5C schematically illustrates a further embodiment of a vascular access device. [Figure 5D] FIG. 5D schematically illustrates a further variation of a vascular access device. DETAILED DESCRIPTION OF THE INVENTION

[0058] The figures depict exemplary embodiments and are intended merely as an aid in understanding the claimed subject matter and are not intended to be limiting in any way.

[0059] 1A-1E schematically illustrate an implantable vascular access device 10. The vascular access device 10 comprises a housing and a reservoir 69 having an outlet lumen 37. The vascular access device further comprises a septum 67 for closing the reservoir 69 and defining the injection region 40.

[0060] The device 10 may further include a visualization system for visualizing the injection area 40 and a controller configured to operate the visualization system. The implantable vascular access device of this embodiment is self-dissecting.

[0061] The injection area in this embodiment is substantially circular, although other shapes and sizes for the injection area 40 are also contemplated.

[0062] In this embodiment, the visualization system includes multiple light emitting devices arranged along the perimeter of the injection area 40. In this embodiment, multiple LEDs 42 are arranged at a relatively short distance from each other to illuminate and indicate the perimeter of the injection area. In some embodiments, the LEDs may have a width or diameter of, for example, 1 mm to 4 mm. The spacing between the LEDs may be, for example, 3 mm to 10 mm.

[0063] The device may further include an energy source, such as one or more batteries. The controller of the device 10 may be configured to activate the visualization system after receiving instructions from the remote control. The controller may be configured to activate all of the LEDs 42 to indicate the injection area after implantation. Electromagnetic radiation emitted from the LEDs 42 can illuminate the patient's skin, making the location of the device 10 visible from the outside. In particular, it is clear from the outside where the injection will be made. The injection only needs to be made within the illuminated injection area.

[0064] In embodiments, the LED 42 may be activated for a predetermined period of time, such as between 20 seconds and 2 minutes, or any period of time deemed sufficient to administer an injection, inject a medication, or draw a blood sample, after which the LED 42 may be turned off.

[0065] In some embodiments, the LEDs 42 may all be activated in the same way. In other embodiments, the LEDs may emit different colored light. For example, different colors may be used for select LEDs to indicate, for example, a preferred area within the injection area for injection. As an example, all LEDs may be initially lit, and after a few seconds, only a specific portion of the LEDs may be lit. The center point between the lit LEDs may represent the "goal" or reference point for the injection. Selective and temporary activation of the LEDs may conserve battery power, extending battery life and the life of the device as a whole.

[0066] One factor limiting the lifespan of an implanted vascular access device is the septum 67. The septum 67 may typically be made of medical-grade biocompatible silicone. Depending on the thickness and overall area of the injection site, a certain number of punctures can be performed before the septum begins to deteriorate and the vascular access device must be replaced. By spreading the injection throughout the injection area (by successively addressing different zones within the injection area), scarring from successive punctures can be reduced, potentially extending the lifespan of the device. Alternatively, the injection area can be made smaller, depending on the desired lifespan.

[0067] Although not shown in the illustrated examples of FIGS. 1A-1E, other systems or methods for externally visualizing the location of an implanted vascular access device can also be used. In an alternative example, the visualization system may consist of an augmented reality device. For example, a professional (e.g., a doctor or nurse) may wear augmented reality glasses. The glasses may include a suitable camera system. The controller may activate a marker (e.g., an LED) located on the device 10, which may be registered by a suitable camera system, and the display on the glasses may assist the professional in navigating to the correct site for injection. In such a case, the marker need not be located on or along the periphery of the injection area 40. As long as the augmented reality system can identify the marker, a visual representation of the vascular access device 10 or injection area 40 may be reproduced.

[0068] The vascular access device 10 may include a first end 30 and an opposing second end 20. An exit lumen 37 may be provided at the first end 30 of the device 10. The first end 30 includes a connector 35 for connection to a catheter. The connector 35 may be made of, for example, titanium or plastic.

[0069] A catheter is not shown in FIGS. 1A-1E, but is shown diagrammatically in FIGS. 1A-2C and 3A-3B as catheter 80. Any catheter suitable for this purpose may be used. For example, the vascular access device 10 may be used in combination with a catheter currently used for the same purpose. The diameter and length of the catheter may be the same as those known in the art and may depend, among other things, on the patient's anatomy. Suitable materials for the catheter include silicone and polyurethane.

[0070] In some embodiments, one or more eyelets 33 may be provided at the first end 30 of the device 10. The eyelets 33 may be used to suture the device 10 to tissue at the implantation site. It is contemplated that the vascular access device 10 will be sized and shaped to reduce the risk of slippage or "flipping" of the vascular access device 10, particularly in embodiments that do not create a pocket for the device to rest in. However, in some cases, as a precaution, additional sutures may be provided at the eyelets 33 to ensure proper positioning and orientation of the device. In other embodiments, such eyelets (or other features suitable for securing or suturing the device in place) may not be necessary.

[0071] The device may further include one or more sensors for measuring patient parameters. The sensors may be located near the second end 40 of the device 10. The sensors may be located on or in relation to the electronics carrier 66, which is depicted here as a box for simplicity. The electronics carrier 60 may be located in a variety of locations. In the illustrated embodiment, a cavity is formed in the housing on the second side 20 of the device 10. The housing may have a tapered section that gradually decreases in height from the injection area toward the end of the device 10. A cavity for receiving the electronics carrier 60 may be provided inside this tapered section.

[0072] The sensors may include, for example, sensors for measuring one or more of body temperature, heart rate, oxygen saturation, or blood glucose. Depending on the type of sensor, the sensor may be positioned in contact with the blood in reservoir 69. Additionally, a timer (e.g., for determining a timestamp of the injection or a timestamp of the activation of the visualization system) and a communication system may be included.

[0073] The electronics carrier 66 may be or may comprise a printed circuit board. The electronics carrier may include logic, described herein as a "controller," for activating and controlling the visualization system. The electronics carrier 66 may include a receiver for receiving instructions and an emitter for transmitting data. In particular, sensor data may be transmitted to a receiver in a data processing system. The data processing system may be a tablet, a smartphone, a general-purpose computer, or the like. Communication with the vascular access device 10 may be based on, for example, NFC, Wi-Fi, Bluetooth, or the like. The electronics carrier 66 may include a power source, such as a battery.

[0074] The data processing system may process and / or analyze and / or store and / or visualize and / or transmit or otherwise process the data. For example, the data may be stored in a hospital's data storage, transmitted to a patient's device (such as a smartphone), or uploaded to a website portal for consultation by the patient and / or a medical professional. Thus, medical records, health information, medications already administered, or other information related to the patient may be stored or retrieved from the patient's device.

[0075] The data processing system may be further configured to send one or more instructions to the controller of the implantable vascular access device. The instructions may include instructions to transmit data, activate one or more LEDs, communicate battery status, etc. In a specific example, an operator may access an appropriate application on a smartphone and send instructions such as to turn on a light for a fixed or manually configurable period of time.

[0076] In a further aspect, a kit is provided that includes an implantable vascular access device according to any of the embodiments disclosed herein and a remote control for sending one or more instructions to a control device of the implantable vascular access device. The remote control device may be the same data processing system that receives and processes sensor data. For example, a smartphone or tablet may be used to send instructions to the vascular access device to activate a visualization system, send measurement data, power on, etc. The device may include an appropriate application, for example, for receiving, storing, and visualizing the received sensor data. The same electronic device may be programmed to generate an alarm signal if the received sensor data indicates an anomaly. Such an anomaly may be a malfunction of the device or its sensors, or an anomaly in the data indicating a potential health problem for the patient.

[0077] The remote control may be a separate device, for example the remote control may be a dedicated device used to activate the visualization system, with a separate electronic device used for data collection.

[0078] The aforementioned warning signals may also be generated by the vascular access device in an out-of-hospital environment, for example, when the patient is at home. The vascular access device may be programmed to determine certain variables (oxygen saturation, cardiac rhythm, etc.) at regular intervals. If an abnormality is detected, a warning signal may be sent to a medical professional and / or the patient's electronic device.

[0079] In some embodiments, the electronics carrier may include a GPS or other location system to allow for patient location when an alert signal is transmitted.

[0080] In a more specific embodiment, the remote control may be integrated into the needle and may send a wake-up or activation command to the vascular access device 10 to illuminate the injection area 40, for example, as the needle device is initially brought close to the patient.

[0081] 1B and 1C show possible dimensions of a vascular access device 10 according to one embodiment. The vascular access device 10 may be smaller, and particularly flatter, than prior art devices. The vascular access device 10 may also be narrower, i.e., have a smaller width, than prior art devices.

[0082] The height of the device may be 10 mm or less, specifically 8 mm or less, and more specifically 6 mm or less. In some embodiments, the height of the device may be on the order of the diameter of a catheter coupled to device 10. In embodiments, device 10 may be configured to be impalpable through a patient's skin. When the visualization system is not activated, device 10 may be configured to be invisible externally.

[0083] In the embodiment shown in FIG. 1B, the width of the device may be approximately 12 mm.

[0084] For comparison, one of the smallest pediatric vascular access devices available on the market is 11 mm tall and 23 mm wide. This is because even the smallest pediatric devices currently available are designed to be palpable, whereas embodiments of the present disclosure do not rely on palpation to locate the device 10.

[0085] The device 10 may be configured to have a generally smooth exterior, i.e., an exterior without sharp corners or protrusions. While sharp corners, protrusions, etc. may improve visibility and aid in palpation of the device's location, they may also cause problems such as skin irritation, infection, or protrusions. In such cases, additional inventions are needed to replace vascular access devices.

[0086] The injection area may also be as small as possible. In other embodiments, the injection area may be larger than the prior art to compensate for any risk of not relying on palpation to locate the device. The injection area may be larger than the prior art to compensate for the perceived risk of not relying on palpation to locate the device. The injection area may be larger than the prior art to compensate for the perceived risk of not relying on palpation to locate the device. The injection area may be larger than the prior art to compensate for any perceived risk of not relying on palpation to locate the device. 2 or 75mm 2 Ultra, specifically 85mm 2 or 85mm 2 Ultra, more specifically 95mm 2 or 95mm 2 It should be noted that, for example, in the designs shown in Figures 1A-1E, the height and width of the vascular access device 10 can be reduced while maintaining substantially the same or even increasing the injection area compared to prior art devices.

[0087] 1D and 1E schematically illustrate the assembly of the components of the vascular access device according to the illustrated embodiment. The septum 67 may have a recess along its periphery. The septum 67 may have a smooth, substantially flat upper surface, i.e., steps or protrusions used in some prior art devices may be avoided.

[0088] A ring-shaped electronic carrier strip 48 of LEDs fits into the recess so that it is substantially flush with the top surface of the septum 67. The electronic carrier strip may be attached to the septum 67 and housing 64 using, for example, a suitable adhesive.

[0089] The vascular access device 10 may further include a puncture-resistant bowl 68, made of, for example, titanium or plastic. The bowl 68 may fit into the housing 64. The bowl 68 may have a through-hole for receiving a connector 35 for a catheter. The housing 64 may have a tapered portion at the second end. The vascular access device 10 may further include a bottom cap 62 that closes the bottom side of the device.

[0090] In other embodiments not shown, the LEDs may be located in different locations, such as under the bowl 68. The septum 67 and bowl may be transparent so that illumination by the LEDs is visible from outside the patient.

[0091] In further embodiments, the specific location of the LEDs relative to the injection area and the number of LEDs can be varied if the injection area is clearly identifiable from outside the patient's body. In embodiments, some of the LEDs may flash, change color, or other cue to indicate the appropriate puncture site to the medical professional, allowing the needle puncture to be varied appropriately (e.g., randomly) over the injection area.

[0092] A method for locating a vascular access device implanted in a patient includes remotely activating a visualization system of the vascular access device 10 to visualize the area surrounding an injection area 40 of the vascular access device 10. The method then includes locating the vascular access device 10 by detecting the area surrounding the injection area 40 while refraining from palpation of the patient.

[0093] In some examples, remotely activating the visualization system may include sending an activation signal from one or more of a personal computer, a tablet, a mobile phone, a smartphone, or a personal digital assistant.

[0094] Figures 2A-2C illustrate further embodiments of a vascular access device 10. The example of Figure 2A substantially corresponds to the example of Figure 1, and in particular Figure 2A corresponds to Figure 1C.

[0095] Figures 2B and 2C show two variations. The height of the two vascular access devices is the same as in the example of Figure 1, i.e., 6 mm. In Figures 2B and 2C, the length of the tapered section is increased. The length L of the tapered section 50 in the example of Figure 2A may be approximately 15 mm. The length of the tapered section 50 in the examples of Figures 2B and 2C may be 30 mm or more, specifically 40 mm or more. Increasing the length of the tapered section makes the instrument suitable for self-dissection. The gradually increasing height may facilitate the introduction of the instrument.

[0096] In the example of Figure 2B, both the upper and lower surfaces of the device taper towards end 20, the height of which corresponds substantially to the midpoint of device connector 35 for connection to a catheter.

[0097] In the example of Figure 2C, the bottom surface is substantially flat, and the top surface tapers downward.

[0098] In an embodiment, the taper angle of the tapered portion is 35° or less, specifically 25° or less, and more specifically 15° or less.

[0099] 3A-3C schematically illustrate a delivery system for delivering a vascular access device, such as the device 10 of FIGS. 1A-1E or any of the examples of FIGS. 2A-2C. The vascular access device may include a first end 30 and a second end 20, and an exit lumen 37 having a device connector 35 for coupling to a catheter disposed at the first end 30. The delivery system includes a tunneler 100 configured to provide a tunnel between the first and second access sites. The tunneler may be further configured to be releasably coupled to the vascular access device 10 at the second end 20 of the vascular access device, i.e., the end opposite to which a catheter 80 may be coupled.

[0100] The terms "first" and "second" access site do not imply a particular order as to when the accesses are made, i.e., the first access site may be made before the second access site, or vice versa.

[0101] The primary access site is the site where the catheter is originally inserted into the appropriate vein, as described in more detail with reference to FIG. 3. The primary access site can be in the patient's neck and subclavian region. The Seldinger technique can be used to place the catheter within the vein. Depending on the situation and the system used, the procedure can include puncturing the skin with a hollow needle to place the catheter within the vein. The catheter, attached to the vascular access device, can be placed within the vein using one or more of a sheath, a dilator, and an introducer catheter. Other techniques for accessing the vein, such as a modified Seldinger technique, a cut-down technique, or an over-the-wire technique, can also be used.

[0102] The second access site is the introduction or exit site of the tunneler. The second access site may be proximate to the implantation site of the vascular access device. In prior art methods and systems, the second access site typically requires an incision (and subsequent suturing) for dissection and subsequent creation of a pocket large enough for the introduction of the vascular access device. While embodiments of the vascular access device may be implanted in the same manner as the prior art, in other embodiments, the vascular access device may be implanted in a manner that reduces scarring, reduces the risk of infection, and may be more comfortable for the patient.

[0103] The tunneler may be used to create a subcutaneous tunnel from a first access site to a second access site, or vice versa. As described in more detail with reference to Figures 3A and 3B, the tunneler may be further configured to release the vascular access device at a location between the first and second access sites.

[0104] The second access site may be in the armpit. In embodiments of the present disclosure, the second access site may be selected in a different area than in prior art methods. Because there is less scarring, the second access site may be more visible and more convenient for the surgeon.

[0105] As previously mentioned, tunneler 100 may be configured to releasably couple to the second end 20 of the vascular access device 10, while catheter 80 is coupled at first end 30. The vascular access device 10 has a device connector for releasably coupling to the tunneler. The device connector may be an eye or eyelet configured to receive a hook 110 of a delivery system. The hook may be opened and closed to respectively hook and unhook tunneler 100 to the vascular access device 10 by medical personnel performing the device implantation.

[0106] In the illustrated embodiment, the hook has two parts that, when closed, form a closed ring that holds the eyelet of the vascular access device, and the two parts are separable to open the ring and allow the eyelet to be removed.

[0107] In a further embodiment, the device-side connector may be a connector for magnetically coupling to a connector on the delivery system. Either the tunneler or the device-side connector may include an electromagnet for actively coupling the device to the tunneler, which can be uncoupled when the device is in place.

[0108] 4A and 4B schematically illustrate one example of a method for delivering a vascular access device 10 to an implantation site. The method includes providing a first access site 122 through the patient's skin and introducing a catheter 80 through the first access site 122 into a vein.

[0109] The vein into which the catheter 80 may be introduced may be any suitable vein, in particular any of the external jugular, internal jugular, cephalic, subclavian and femoral veins.

[0110] The method may further include providing a second access site 124 through the patient's skin and providing a tunnel between the first and second access sites using the tunneler 100.

[0111] As previously mentioned, numbering an access site as "second" does not imply that the second access site is created after the first. A tunnel may be created by introducing the tunneler 100 from the second access site into the first access site 122.

[0112] As previously mentioned, a variation of the Seldinga technique may be used to position one end of the catheter 80 within a vein. Providing a first access site may include puncturing the skin with a hollow needle until the distal end of the hollow needle reaches the vein, and introducing a guidewire through the hollow needle and into the vein. The catheter may be further positioned within the selected vein using a sheath and / or dilator.

[0113] The other end of the catheter may be coupled to a vascular access device, such as connector 35. The appropriate length of catheter 80 may be determined based on the selected implantation site of vascular access device 10, and the catheter may be cut to the appropriate length.

[0114] Next, the method includes releasably coupling tunneler 100 to vascular access device 10 and moving tunneler 100 from first access site 122 toward second access site 124 to pull vascular access device 10 toward second access site 124. That is, contrary to prior art methods, the vascular access device is introduced into the patient's body at first access site 122 (the same access site for placing a catheter in a vein) rather than at second access site 124.

[0115] The incision at the second site may be smaller than in the prior art: the incision at the second site may be less than 0.5 cm in length, specifically less than 3 mm in length, and more specifically 2 mm or less in length.

[0116] Once the vascular access device 10 has been pulled by the tunneler, the method then includes releasing the vascular access device 10 at the implantation site, after which the tunneler may be further pulled and emerge from the second access site, leaving the vascular access device in place.

[0117] In some embodiments, creating a tunnel between the first access site 122 and the second access site 124 and pulling the vascular access device 10 toward the second access site 124 can occur in parallel, i.e., the tunnel is formed as the vascular access device 10 is pulled due to its autodissecting nature.

[0118] In other embodiments, a tunnel is provided from a first access site to a second access site using tunneler 100, after which tunneler 100 is releasably coupled to the vascular access device and the tunneler is moved from the first access site to the second access site.

[0119] The method may further include visualizing the vascular access device and / or catheter while the vascular access device is being withdrawn from the first access site to the second access site. Visualization may include visualization using x-rays to confirm proper catheter placement. The catheter may have radiopaque markers at appropriate locations. In some embodiments, the vascular access device may include radiopaque markers for visualization using x-rays. Pulling on the vascular access device may exert a traction force on the catheter. X-ray visualization may be performed to confirm proper placement of the catheter. The ability to properly position the vascular access device is especially important in children, whose anatomy varies greatly with age.

[0120] A visualization system on the vascular access device for visualizing the injection area may also be used during implantation to define where future punctures will be made.

[0121] FIG. 4C illustrates a variation of a method for implanting a vascular access device. As has been described throughout this disclosure, the vascular access device may be smaller and thinner than prior art devices. The relatively small size of the device may also be implanted in the patient's arm. One aspect of implanting a device in the patient's arm is that such a procedure can be performed with only local anesthesia and does not require a fully equipped operating room. Venous access may be achieved using the Selzinga technique, where a catheter may be advanced into a deep vein in the middle of the arm.

[0122] The catheter may be coupled to the end of the vascular access device as described in the previous examples, and introduction of the catheter and vascular access device may be accomplished through a single incision in the arm.

[0123] 5A-5C schematically illustrate a further embodiment of a vascular access device. Generally, this vascular access device is generally similar in size, use, and potential implantation methods to the other embodiments illustrated herein. Materials are also similar to the previously described embodiments.

[0124] Figure 5A shows an isometric view of the device, Figure 5B shows the device in longitudinal cross section, and Figure 5C is an isometric view of the vascular access device with the outer housing removed to show the interior of the device.

[0125] The vascular access device includes a housing and a reservoir having an outlet lumen 37. The vascular access device may include a connector 35 for connecting to a catheter. The reservoir is formed between a bowl 68 and a septum 67. The area above the septum 67 may define an injection area 40.

[0126] A number of light emitting devices, in particular LEDs 42, may be arranged along the periphery of the septum 67. In this example, the device comprises 14 LEDs.

[0127] The LEDs 42 may be selectively activated as described above. For example, a mobile phone or smartphone equipped with Bluetooth technology may be used to establish communication with the device. When the device is "activated," all or a subset of the LEDs 42 may be activated. As previously described, all LEDs may be the same color, or different colored LEDs may be used. They may be programmed in an appropriate manner to allow for injection and to vary the injection site by indicating to the healthcare professional where the next injection site is preferred.

[0128] As illustrated herein, the device may have a tapered portion to facilitate self-dissection, in this embodiment a septum 67 is disposed within and forms part of the tapered portion.

[0129] In the example of Figure 5, the device may include multiple batteries. In particular, four batteries are shown. Contrary to other embodiments, the bowl 68 is positioned above four batteries 71. In the specific example, four 1.4V zinc cells are shown. As an example, Duracell® DA312 batteries may be used.

[0130] Since the bowl 68 is located above the battery, the height of the bowl 68 may be lower compared to previous embodiments so as not to increase the overall height of the device. Similarly, the connector 35 and bore 37 are located higher than in other embodiments.

[0131] The device of Figure 5 includes an electronics carrier 66, which may be or may include a printed circuit board. The electronics carrier may include logic, described herein as a "controller," for operating and controlling the visualization system. The electronics carrier 66 may include Bluetooth technology for communicating with, for example, a smartphone, tablet, or other device. The electronics carrier 66 may include one or more sensors, similar to those illustrated in other embodiments.

[0132] The device shown in Figure 5 may be 10mm high, 12mm wide and approximately 40mm long.

[0133] FIG. 5D illustrates a further variation of the vascular access device. This variation is based on the device shown in FIGS. 5A-5C. FIG. 5D generally corresponds to FIG. 5C. In this example, a catheter 80 is coupled to first end 30, while a tunneler (e.g., tunneler 100 shown in other figures) may be releasably coupled to second end 20 of vascular access device 10. The vascular access device 10 has a device connector for releasably coupling to the tunneler. The device connector may be an eye, eyelet, or opening configured to receive hook 110 or other coupling feature of the delivery system. The hook may be opened and closed by the medical professional implanting the device, allowing tunneler 100 to be hooked and unhooked, respectively, to the vascular access device 10.

[0134] The implantation and positioning of the vascular access device of FIG. 5D may be performed using methods such as those described with reference to FIG.

[0135] For completeness, numerous aspects of this disclosure are set forth in the following numbered sections. (Section 1) 1. An implantable vascular access device, comprising: Housing and a reservoir having an outlet lumen; a septum closing the reservoir and defining an injection area; a visualization system for visualizing the injection area; a controller configured to activate the visualization system; Equipped with Self-dissection is possible, Device. (Section 2) The injection area is 75 mm 2 or 75mm 2 Ultra, specifically 85mm 2 or 85mm 2 Ultra, more specifically 95mm 2 or 95mm 2 2. The apparatus of claim 1, having a size greater than (Section 3) 3. The device of claim 1 or 2, wherein the height of the device is 10 mm or less, particularly 8 mm or less, more particularly 6 mm or less. (Section 4) 4. The device of any of claims 1 to 3, wherein the housing has a tapered portion, optionally having a length of at least 15 mm, particularly greater than 30 mm. (Section 5) configured so as not to be palpable through the patient's skin; 5. The device according to any one of paragraphs 1 to 4. (Section 6) The injection area is substantially obround. 6. A device according to any one of paragraphs 1 to 5. (Section 7) the visualization system comprises one or more light emitting devices positioned along a periphery of the injection area; 7. A device according to any one of paragraphs 1 to 6. (Section 8) the visualization system comprises an augmented reality device; 8. A device according to any one of paragraphs 1 to 7. (Section 9) the visualization system is configured to indicate the periphery of the injection area; 9. A device according to any one of paragraphs 1 to 8. (Section 10) further comprising an energy source, optionally a battery; 10. A device according to any one of paragraphs 1 to 9. (Section 11) the controller is configured to activate the visualization system after receiving an instruction from a remote control; 11. A device according to any one of paragraphs 1 to 10. (Section 12) the visualization system is configured to activate at a predetermined time, and optionally, the visualization system is configured to indicate a puncture site within the injection area. 12. A device according to any one of paragraphs 1 to 11. (Section 13) the outlet lumen is located at a first end of the device; 13. The device of any of paragraphs 1 to 12, further comprising a device-side connector for releasably coupling to a connector of the delivery system. (Section 14) the device-side connector is an eye or eyelet configured to receive a hook of the delivery system; 14. The device according to paragraph 13. (Section 15) the device connector is a connector that magnetically couples to a connector of the delivery system; 14. The device according to paragraph 13. (Section 16) further comprising one or more sensors for measuring patient parameters; 16. A device according to any one of paragraphs 1 to 15. (Section 17) further comprising an emitter for transmitting data to a receiver; 17. A device according to any one of paragraphs 1 to 16. (Section 18) 18. A system comprising the device of claim 16 or 17, further comprising a data processing system having a receiver for receiving data transmitted by the transmitter of said device and a database for storing said received data; system. (Section 19) further comprising a display for visualizing the received data; 19. The system of claim 18. (Section 20) The data processing system is a personal computer, a tablet, a mobile phone, a smartphone, or a personal digital assistant. 19. The system according to claim 18 or 19. (Section 21) the data processing system is further configured to send one or more instructions to the controller of the implantable vascular access device. 21. A system according to any one of paragraphs 18 to 20. (Section 22) 18. An implantable vascular access device according to any one of claims 1 to 17; a remote control for sending one or more instructions to the controller of the implantable vascular access device; Equipped with kit. (Section 23) The remote control is a personal computer, a tablet, a mobile phone, a smartphone, or a personal digital assistant. 23. The kit of claim 22. (Section 24) The remote control is integrated into the needle. 23. The kit according to item 22. (Section 25) Housing and a reservoir having an outlet lumen; a septum for closing the reservoir and defining an injection area; one or more sensors positioned to measure one or more parameters of blood in the reservoir; a transmitter for transmitting the measured parameters; Equipped with Implantable vascular access devices. (Section 26) the sensor is configured to measure one or more of body temperature, heart rate, oxygen saturation, and blood glucose level; 26. The device according to paragraph 25. (Section 27) a visualization system for visualizing the injection area; a controller configured to operate the visualization system; Further provided with 27. The device according to paragraph 25 or 26. (Section 28) the visualization system having one or more light sources configured to indicate the periphery of the injection area; 28. The device according to paragraph 27. (Section 29) the housing comprises a tapered section having a transmitter and an electronics support section, optionally the tapered section having a length of 15 mm or greater than 15 mm, and optionally the tapered section having one or more taper angles of 35° or less than 35°; 29. A device according to any one of paragraphs 25 to 28. (Section 30) configured to be impalpable through the patient's skin; 30. A device according to any one of paragraphs 25 to 29. (Section 31) The injection area is substantially oval. 31. A device according to any one of paragraphs 25 to 30. (Section 32) The outer contour is substantially smooth; 32. A device according to any one of paragraphs 25 to 31. (Section 33) 33. A system comprising the device of any one of paragraphs 25 to 32, a data processing system having a receiver for receiving the parameters transmitted by the transmitter; system. (Section 34) The data processing system is a personal computer, a tablet, a mobile phone, a smartphone, or a personal digital assistant. 34. The system of claim 33. (Section 35) the data processing system is further configured to send one or more commands to the controller of the implantable vascular access device. 35. The system according to claim 33 or 34. (Section 36) 1. A method for locating a vascular access device implanted in a patient, comprising: remotely activating a visualization system of the vascular access device to visualize the area surrounding the injection region of the vascular access device; locating the vascular access device by detecting the perimeter of the injection area while refraining from palpation of the patient; A method comprising: (Section 37) remotely activating the visualization system includes sending an activation signal from one or more of a personal computer, a tablet, a mobile phone, a smartphone, or a personal digital assistant; 37. The method according to paragraph 36. (Section 38) the visualization system is configured to visualize the surroundings of the injection area for a predetermined period of time; 38. The method according to paragraph 36 or 37. (Section 39) The height of the vascular access device is less than 10 mm, specifically less than 8 mm, and more specifically 6 mm or less; 39. The method of any one of paragraphs 36 to 38. (Section 40) the vascular access device is not visible from outside the patient when the visualization system is not activated; 39. The method of any one of paragraphs 36 to 39. (Section 41) 1. A delivery system for delivering a vascular access device, particularly a self-dissecting vascular access device, comprising: the vascular access device having a first end and a second end and an outlet lumen having a device connector disposed at the first end for coupling to a catheter; 1. A tunneler configured to provide a tunnel between a first access site and a second access site, comprising: the tunneler is further configured to be releasably coupled to the vascular access device at the second end of the vascular access device. Delivery system. (Section 42) the tunneler is configured to release the vascular access device at a location between the first access site and the second access site. 42. The delivery system of claim 41. (Section 43) the first access site is near the patient's neck or subclavian; 43. A delivery system according to paragraph 41 or 42. (Section 44) the second access site is in the patient's underarm region; 44. The delivery system of paragraph 43. (Section 45) 1. A method of delivering a vascular access device, particularly a self-dissecting vascular access device, to an implantation site, comprising: providing a first access site through the patient's skin; introducing a catheter into the vein through the first access site; providing a second access site through the skin of the patient; providing a tunnel between the first access site and the second access site with a tunneler; releasably coupling the tunneler to the vascular access device and moving the tunneler from the first access site toward the second access site to pull the vascular access device toward the second access site; Releasing the vascular access device at the implantation site; Including, method. (Section 46) establishing the tunnel between the first access site and the second access site and pulling the vascular access device toward the second access site are performed concurrently. 45. The method of claim 45. (Section 47) providing the tunnel from the first access site to the second access site using the tunneler, after which the tunneler is releasably coupled to the vascular access device and the tunneler is moved from the first access site to the second access site. 45. The method of claim 45. (Section 48) providing the first access site includes puncturing the skin with a hollow needle; puncturing the distal end of the hollow needle to reach a vein; introducing a guidewire through the hollow needle into the vein. 48. A method according to any one of paragraphs 45 to 47. (Section 49) providing the second access site includes incising the skin; The incision is less than 0.5 cm in length, particularly less than 3 mm in length, more particularly less than 2 mm or less in length; 49. A method according to any one of paragraphs 45 to 48. (Section 50) the tunneler is releasably mechanically coupled to the vascular access device; 49. A method according to any one of paragraphs 45 to 49. (Section 51) the tunneler includes a hook for coupling with an eye or eyelet of the vascular access device. 50. The method according to paragraph 50. (Section 52) and visualizing the vascular access device and / or the catheter while the vascular access device is being pulled from the first access site to the second access site. 52. A method according to any one of paragraphs 45 to 51. (Section 53) The visualizing includes visualizing using X-rays. 52. The method of claim 52. (Section 54) The height of the vascular access device is less than 10 mm, specifically less than 8 mm, and more specifically 6 mm or less; 54. A method according to any one of paragraphs 45 to 53. (Section 55) the vascular access device comprising one or more sensors positioned to measure one or more parameters of blood in the reservoir; and a transmitter for transmitting the measured parameters. 55. A method according to any one of paragraphs 45 to 54. (Section 56) the vascular access device has a tapered portion. 56. A method according to any one of paragraphs 45 to 55. (Section 57) The tapered portion has a length of 15 mm or more, specifically 30 mm or more; 56. The method of claim 56. (Section 58) The tapered portion has one or more taper angles of 35° or less, in particular 20° or less, 58. The method of claim 56 or 57.

[0136] While only a number of examples have been disclosed herein, other alternatives, modifications, uses, and / or equivalents are possible. Furthermore, all possible combinations of the examples described are also covered. Accordingly, the scope of the present disclosure should not be limited by specific examples, but should be determined solely by a fair reading of the claims that follow.

Claims

1. An implantable vascular access device, Housing and A reservoir with an outlet lumen, A septum for closing the reservoir and defining the injection area, A visualization system for visualizing the injection area, A controller configured to activate the visualization system after receiving instructions from a remote control device, Equipped with, It is capable of self-dissection, The height of the aforementioned device is less than 10 mm. Device.

2. The height of the aforementioned device is less than 8 mm, more specifically 6 mm or less than 6 mm. The apparatus according to claim 1.

3. Designed to be undetectable by touch through the patient's skin, The apparatus according to claim 1.

4. The apparatus according to claim 1, comprising a smooth outer surface free from sharp corners, bumps, steps, and protrusions.

5. It also features a tapered section, Selectively, the angle of the taper is less than 35°. The apparatus according to claim 1.

6. The tapered portion has a length of at least 15 mm, specifically more than 30 mm. The apparatus according to claim 5.

7. The injection area is 75 mm 2 or 75mm 2 More specifically, 85mm 2 or 85mm 2 More specifically, 95mm 2 or 95mm 2 Having an enormous size, The apparatus according to claim 1.

8. The visualization system comprises one or more light-emitting devices arranged along the periphery of the injection area. The apparatus according to claim 1.

9. The apparatus according to claim 8, wherein the light-emitting device is programmed to indicate the puncture site within the injection area.

10. The apparatus according to claim 9, wherein the light-emitting device is programmed to change the puncture site within the injection area.

11. Further comprising one or more sensors for measuring patient parameters, The apparatus according to claim 1.

12. The sensor is configured to measure one or more of the following: body temperature, heart rate, oxygen saturation, and blood glucose level. The apparatus according to claim 11.

13. It also includes an emitter for transmitting data to the receiver. The apparatus according to claim 1.

14. The apparatus according to claim 1, further comprising an energy source.

15. The apparatus according to claim 1, configured to be powered remotely.

16. The outlet lumen is provided at the first end of the device, The apparatus according to claim 1, further comprising an apparatus-side connector for releasably connecting to a connector of a delivery system.

17. A delivery system for delivering the vascular access device described in claim 16, The vascular access device has a first end and a second end, and an outlet lumen having a device-side connector for connecting to a catheter positioned at the first end, The system includes a tunnel configured to provide a tunnel between a first access point and a second access point, where, The tunneler is further configured to be releasably connected to the vascular access device at the second end of the vascular access device. Delivery system.

18. The tunneler is configured to release the vascular access device at a position between the first access site and the second access site. The delivery system according to claim 17.

19. A system comprising the apparatus described in any one of claims 1 to 18, A data processing system comprising: a receiver for receiving data transmitted by the transmitter of the aforementioned device; and a database for storing the received data. Furthermore, The data processing system is selectively a personal computer, tablet, mobile phone, smartphone, or personal digital assistant. system.

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