Systems, methods, and devices for locating and accessing implant ports

Abstract

A system, method, and apparatus are disclosed to locate and access a drug administration access port implanted beneath the skin of a patient, particularly by a user lacking clinical training or professional knowledge, such as the patient itself. An apparatus for use with an access port may include a locator assembly and a base plate. The base plate may include an adhesive flange to adhere the base plate to the skin of a patient, and the adhesive flange may include at least one opening. The base plate may also include a base coupler located on the adhesive flange and having at least one opening. The base coupling may cooperate with the locator assembly such that the base plate is attachable to and detachable from the locator assembly and the drug applicator. A drug applicator may apply a drug to a patient through the adhesive flange and the opening of the base coupler.

Description

[0001] Cross-reference to related applications This application claims the benefit of priority to U.S. Provisional Patent Application 63 / 448,136 (MTCH-0001-P01), filed on February 24, 2023, entitled “Implanted Port Locating Apparatus and Method”.

[0002] The aforementioned application is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] The principles and embodiments of this disclosure may relate to improvements for drug delivery via an implantable access port. For example, embodiments of this disclosure may relate to improved apparatus and methods for positioning aspects of an implantable access port prior to delivery of one or more therapeutic drugs. Further, embodiments of this disclosure may relate to improvements for simplifying the administration of drugs via a positioned access port using a drug delivery device such as a port access needle, wearable syringe, or handheld syringe. Background Technology

[0004] Infusion and injection are medical procedures used to deliver a wide range of therapeutic agents for various diseases. Infusion, injection, and administration can be performed via subcutaneous (SC), intramuscular (IM), intravenous (IV), or enteral routes. The route of administration may be based on the pharmacokinetic (PK) distribution of the specific drug, formulation components, approved regulatory labeling, individual clinical judgment, or clinical necessity.

[0005] Infusion and injection can be performed via the intravenous (IV) route, which allows medications to be delivered to various parts of a patient's venous system. IV administration may require direct access to the patient's vein using a needle, catheter, or implantable venous port. Biologics are frequently administered via the IV route. SC administration is generally considered less invasive and more direct for the patient. Both IV and SC administration can be used to treat a wide range of conditions, especially chronic ones.

[0006] One method of IV and SC administration of medications uses implantable access ports. These access ports can remain in place for weeks to years, making them particularly advantageous for delivering treatment regimens administered over long timeframes (often weeks apart). Access ports reduce the risk of infection, provide patients with autonomy due to their location under the skin, and allow them to continue with normal daily activities. As a result, they are increasingly used, especially as chronic diseases become more prevalent, treatments become more intensive, and medications must be administered repeatedly over longer periods.

[0007] Access ports typically include a port housing defining a cavity, a septum sealing the open end of the cavity, and an outlet in fluid communication with the catheter. The catheter can then be positioned in fluid communication with a part of the patient's anatomy (such as the venous system) during port implantation. The septum may be generally elastomeric and designed to be repeatedly punctured by a needle and resealed after needle removal. Access ports vary in size, shape, material, profile, number of septa, and number of catheter tubes. Ports can be used to provide physiological access via IV, SC, IM, intrathecal, or other routes of administration.

[0008] Manual port location Ports can typically be located by palpating the skin near the intended location of the implanted access port (e.g., above the intended location). Palpation can be used to attempt to identify which type of port has been placed and to verify the intended port orientation (e.g., septum facing upwards toward the skin surface). Port identification can be important to ensure that the type of implanted port is suitable for the planned infusion and that the correct needle assembly can be selected. The size, shape, and other tactile markers on the port (e.g., protrusions on the port housing or septum, indentations on the port septum) can also be used to distinguish the type of implanted port. Patients may be instructed to carry a port identification card or band that details the type of implanted port they have, the time of implantation, and the person who placed the port (e.g., an individual clinician or medical facility).

[0009] For example, U.S. Patent No. 8,608,713 to Beasley et al. and U.S. Patent No. 10,052,471 to Hamatake et al. describe protrusions on the diaphragm of an access port for palpation and identification. However, protrusions may not be intuitive to all users and / or may lead to erosion sites requiring removal of the access port. Furthermore, palpation may not be precise enough to identify specific port locations or incorrect configurations. For example, it may be limited by the tactile sensitivity and experience of the practitioner. Therefore, while palpation is useful for healthcare providers who have received specialized training in implanted port access, the ability to distinguish port shape, contour, or orientation may still vary.

[0010] Furthermore, laypeople, including patients and their caregivers, may lack the expertise to locate and access ports, identify port types, and recognize potential complications associated with implanted ports. This can be particularly problematic when medication delivery occurs at home.

[0011] To supplement palpation, or when tactile sensitivity is insufficient to identify ports, or when port-related complications are suspected, radiographic imaging can be used to visualize ports and identify port types. Optionally, additional identifiers provided with the access port can be used to assist such imaging studies. Port-related physical complications that are difficult to detect by palpation alone can also be identified through imaging studies.

[0012] Physical complications may include port repositioning, such as catheter dislocation from the port body due to inversion or rotation (e.g., secondary to patient manipulation or "twisting syndrome"), or port or catheter breakage. Inversion can refer to the port being flipped over, where the septum surface faces inward toward the body cavity instead of outward toward the skin as expected.

[0013] Skin & Area Preparation Once the port has been located, identified, and any complications (e.g., port inversion) have been ruled out, the skin near the access port can be prepared. Optional preparation steps can reduce skin or soft tissue discomfort during subsequent insertion of the access needle. A local anesthetic (e.g., a cream containing lidocaine and prilocaine) can be applied to the skin, or a local injection (e.g., lidocaine) can be given into the skin or subcutaneous tissue near the access port. This procedure can be based on patient and / or clinician preferences or protocols in the application setting.

[0014] While local anesthetics may be used optionally, the skin near the access port should be routinely and carefully disinfected before insertion. Maintaining aseptic technique is important throughout the procedure, regardless of the application environment, route of administration, or the design of the implantable port used. For example, with IV access ports, poor aseptic technique can lead to undesirable or harmful microbial contamination of the IV line. This central tubing-associated bloodstream infection (CLABSI) can be life-threatening and requires acute, intensive antibiotic treatment or removal of the access port, interrupting treatment and eliminating the critical IV access device, especially in patients with chronic illnesses. Similarly, adverse sequelae can result from contamination of SC access ports. Because the port is inserted for an extended period, sterilizing agents with persistent antimicrobial activity, such as chlorhexidine gluconate, can be selected.

[0015] Port access & drug administration To deliver medications to patients with implantable access ports, a needle and tubing assembly can be used. One end of the tubing assembly may be fitted with a non-core-removing needle (such as a Huber needle), which is designed to prevent damage to the septum during insertion and removal. A Huber needle can refer to a hollow-hole percutaneous needle with a bent cannula and a deflected sharp end for entry into the port septum without core removal. When the needle is removed from the septum, the bent cannula and deflection point design maintain the septum's self-sealing properties as a sterile and fluid barrier. Clamps may be fitted onto the tubing assembly to start or stop fluid flow. Flexible wings (if provided) assist in gripping the relatively small needle assembly and accurately placing it into the septum. The opposite end of the tubing assembly may typically be fitted with a Luer connector or Luer-Lok® fitting for connection to a fluid delivery system, such as a pump commonly found in inpatient and outpatient settings.

[0016] One end of the tubing assembly can be connected to a drug reservoir, such as a syringe or IV extension kit. Using aseptic techniques, the needle is placed over the skin covering the port septum and then sequentially advanced through the skin, subcutaneous tissue, and port septum, thereby positioning the tubing assembly in fluid communication with the access port cavity and thus the patient's venous system. A occlusive dressing can be used to secure the needle assembly to prevent accidental movement, dislocation, and contamination. Once positioned and secured, medication can be administered to the patient. Once administration is complete, the process can be reversed; the needle retainer is removed and the needle withdrawn from the port septum and patient skin at the access port, allowing both layers to self-seal and re-establish an effective barrier against contamination. Because the exposed needle is in fluid communication with the patient's bloodstream, some needle designs may include protective mechanisms to prevent injury from a potentially contaminated needle tip during or after removal from the septum or skin.

[0017] While the concept of accessing an implantable port may seem straightforward, the process of locating and preparing the port for access can be complex and technically sensitive. Currently, limitations of the available technology restrict port location, skin examination, skin preparation, port access, and medication delivery to healthcare-trained personnel. For patients without such training and their non-clinical caregivers, these steps can be overwhelming. As a result, many patients who could benefit from treatments utilizing access ports remain deprived of access.

[0018] There is a need for improved systems, methods, and devices to allow undertrained users (such as patients or non-clinical patient caregivers) to easily and intuitively locate the implantation port. There is also a need for improved systems, methods, and devices to allow undertrained users (such as patients or non-clinical patient caregivers) to reliably sterilize the port, aseptically access the port, and administer one or more medications as if using a needle from a drug delivery device. Such improvements could allow patients to assume greater self-care responsibility without sacrificing safety or drug efficacy. Furthermore, such improvements could allow a wider range of patients to benefit from the use of the access port and could allow for the treatment of a wider range of diseases in more convenient and less burdensome settings (such as the home). Summary of the Invention

[0019] In some aspects, the technology described herein relates to a device for use with an access port implanted in a living organism, the device comprising: a locator assembly including: a sensor configured to sense an aspect of the access port, wherein the aspect includes at least two different material densities of the access port; a controller configured to determine the location of the access port based on the at least two different material densities of the access port, wherein the at least two different material densities correspond to at least two different elements of the access port, including at least one of a port housing or an elastomer capable of piercing a port diaphragm; and an output device configured to provide feedback to a user, wherein the controller is further configured to instruct the output device to provide feedback to the user based on the determined location of the access port.

[0020] In some respects, the technology described herein relates to a device in which the access port is a subcutaneous access port.

[0021] In some respects, the technology described herein relates to a device in which an access port is structured for subcutaneous or intravenous drug delivery.

[0022] In some respects, the technology described herein relates to a device in which the sensors include multiple ultrasonic (UT) sensors.

[0023] In some respects, the technology described herein relates to a device in which: a sensor includes a central sensor and a plurality of peripheral sensors arranged in a concentric pattern around the central sensor; and when the locator assembly is positioned over an access port, the central sensor corresponds to an elastomeric piercing port diaphragm, and the plurality of peripheral sensors correspond to a port housing surrounding the elastomeric piercing port diaphragm.

[0024] In some respects, the technology described herein relates to a device in which the at least two distinct elements comprise a port housing and an elastomer capable of piercing a port diaphragm, and the material of the port housing is denser than the material of the elastomer capable of piercing the port diaphragm.

[0025] In some respects, the technology described herein relates to a device in which a controller is further configured to identify one or more regions of an elastomer-perforable port diaphragm, and wherein each of these regions corresponds to a perforable diaphragm of a discrete lumen connected to an access port.

[0026] In some respects, the technology described herein relates to a device in which: based on sensing from a sensor, a controller is also configured to identify an aspect of a puncturable elastomeric port diaphragm or port housing; and the aspect includes at least one of geometry, profile, or material.

[0027] In some respects, the technology described herein relates to a device in which the controller is also configured to identify at least one of the design, model, or manufacturer of the access port based on this aspect of the port housing.

[0028] In some respects, the technology described herein relates to a device in which an output device includes a wireless interface for communicating with a remote device, and a controller is configured to provide a determined location to the remote device via the wireless interface.

[0029] In some respects, the technology described herein relates to a device in which the remote device is a smartphone device.

[0030] In some respects, the technology described herein relates to a system comprising: the device; and a non-transitory computer-readable storage medium storing instructions that, when executed by at least one processor of a remote device, include: receiving a determined position from an output device; and instructing a display of the remote device to provide feedback to a user in a visual form.

[0031] In some respects, the technology described herein relates to a device in which the feedback is at least one of tactile, visual, or auditory.

[0032] In some respects, the technology described herein relates to a device in which: feedback includes directional feedback; and the controller is further structured to instruct the output device to provide directional feedback to the user, such that the directional feedback indicates both the direction of movement of the device for direct overlap with the access port and the relative proximity of the access port.

[0033] In some respects, the technology described herein relates to a device in which the controller is also configured to detect the orientation of the access port under the skin of a living organism based on sensing from sensors.

[0034] In some respects, the technology described herein relates to a device in which the controller is also structured to detect an inverted orientation of the access port beneath the skin based on determining the bottom-up orientation of the implanted access port toward the skin.

[0035] In some respects, the technology described herein relates to a device that further includes a base plate having an adhesive for adhesion to the skin of a living body, wherein the locator assembly and the base plate are configured to attach and detach from each other.

[0036] In some respects, the technology described herein relates to a device in which a base plate is configured to cooperate with a drug delivery device.

[0037] In some respects, the technology described herein relates to a device in which the sensors include multiple ultrasonic sensors.

[0038] In some respects, the technology described herein relates to a method for locating an access port implanted in a living organism, the method comprising: sensing an aspect of the access port using sensors of a locator assembly, wherein the aspect includes at least two different material densities of the access port, and the at least two different material densities correspond to at least two different elements of the access port, including at least one of a port housing or an elastomer capable of piercing a port diaphragm; determining the location of the access port based on the distinction of the at least two different material densities of the access port; and outputting feedback to a user based on the determined location of the access port.

[0039] In some respects, the techniques described herein relate to a method in which outputting feedback to a user includes providing the user with directional feedback, which includes both the direction of movement of the locator component for direct overlap with the access port and the relative proximity of the access port.

[0040] In some respects, the techniques described herein relate to a method in which outputting feedback to a user includes outputting feedback to a remote device via a wireless interface.

[0041] In some respects, the techniques described herein relate to a method in which feedback is provided via a locator component, and the feedback is at least one of tactile, visual, or auditory.

[0042] In some aspects, the technology described herein relates to a device for use with an access port implanted in a living body, the device comprising: a locator assembly including: at least one port sensor configured to sense one aspect of the access port; at least one skin sensor configured to sense proximity of the device to the skin of the living body; a controller configured to determine the location of the access port based on the aspect sensed by the at least one port sensor, wherein the controller instructs the at least one port sensor to sense the aspect based on proximity of the device to the skin as sensed by the at least one skin sensor; and an output device configured to provide feedback to a user, wherein the controller is further configured to instruct the output device to provide feedback to the user based on the determined location of the access port.

[0043] In some respects, the technology described herein relates to a device in which: when the at least one skin sensor indicates that the device is more than a predetermined threshold away from the skin, a controller instructs the at least one port sensor to sense the aspect at a first time interval; when the at least one skin sensor indicates that the device is at or within the predetermined threshold away from the skin, the controller instructs the at least one port sensor to sense the aspect at a second time interval; and the first time interval is slower than the second time interval.

[0044] In some respects, the technology described herein relates to a device in which a predetermined threshold distance from the skin corresponds to the height of an access port to take into account the prominence of the access port beneath the skin.

[0045] In some respects, the technology described herein relates to a device in which a predetermined threshold is between 0.5 inches and 1.0 inches, including the end value.

[0046] In some respects, the technology described herein relates to a device in which: a first time interval and a second time interval correspond to the sampling rate of the at least one port sensor; the first time interval is at or below a frequency of 500 Hz; and the second time interval is between a frequency of 750 Hz and 1000 Hz, including the end value.

[0047] In some respects, the technology described herein relates to a device in which the frequency of a second time interval increases as the distance between the skin sensor indicating the device and the skin decreases.

[0048] In some respects, the technology described herein relates to a device in which: the at least one skin sensor includes a capacitive sensor and a pogo pin; the capacitive sensor senses the proximity of the device to the skin; and the pogo pin senses contact with the skin.

[0049] In some respects, the technology described herein relates to a device in which the at least one port sensor includes an ultrasonic sensor.

[0050] In some respects, the techniques described herein relate to a device in which at least one of a capacitive sensor or a spring pin is electromagnetically shielded using a shielding element to prevent electromagnetic interference (EMI) from the spring pin from interfering with the sensing of the capacitive sensor.

[0051] In some respects, the technology described herein relates to a device in which a controller controls the power to a spring needle so that contact with the skin is sensed only when the proximity of the device to the skin is within a predetermined threshold.

[0052] In some respects, the technology described herein relates to a device in which a predetermined threshold corresponds to the height of an access port to take into account any protrusion of the access port beneath the skin.

[0053] In some respects, the technology described herein relates to a device in which: the at least one skin sensor comprises a capacitive sensor; and the device includes a structure for preventing interference with the sensing of the capacitive sensor.

[0054] In some respects, the technology described herein relates to a device in which the output means includes a visual indicator configured to indicate at least one of the orientation or proximity of the access port relative to the device.

[0055] In some respects, the technology described herein relates to a method for using an access port subcutaneously implanted in a living body, the method comprising: sensing proximity to the skin using at least one skin sensor of the device; instructing at least one port sensor to sense one aspect of the access port based on the proximity to the skin; sensing that aspect of the access port using the at least one port sensor; determining the location of the access port by a controller based on the aspect sensed by the at least one port sensor; and providing feedback to a user via an output device based on the determined location of the access port.

[0056] In some respects, the techniques described herein relate to a method in which sensing proximity to skin further includes: sensing the aspect at a first time interval when the at least one skin sensor indicates that the device is more than a predetermined threshold away from the skin; and sensing the aspect at a second time interval when the at least one skin sensor indicates that the device is at or within the predetermined threshold away from the skin, wherein the first time interval is slower than the second time interval.

[0057] In some respects, the techniques described herein relate to a method in which a predetermined threshold distance from the skin corresponds to the height of the access port, taking into account any protrusion of the access port beneath the skin.

[0058] In some respects, the techniques described herein relate to a method in which: a first time interval and a second time interval correspond to the sampling rate of the at least one port sensor; the first time interval is at or below a frequency of 500 Hz; and the second time interval is between a frequency of 750 Hz and 1000 Hz, including the end value.

[0059] In some respects, the technology described herein relates to a method in which the at least one skin sensor includes a spring needle, and the method further includes controlling the power to the spring needle so that contact with the skin is sensed only when the proximity of the device to the skin is within a predetermined threshold.

[0060] In some aspects, the technology described herein relates to a device for use with an access port implanted subcutaneously in a living organism, the device comprising: a locator assembly including: a port sensor configured to sense one aspect of the access port; a controller configured to determine the location of the access port based on the aspect sensed by the port sensor; and an output device configured to provide feedback to a user, wherein the controller is further configured to instruct the output device to provide feedback to the user based on the determined location of the access port, the locator assembly further comprising a housing in which the controller is located, the housing including a device-side connector; and a base plate including: adhesive... An adhesive flange configured to adhere a base plate to the skin of a living organism, the adhesive flange including at least one opening; and a base connector located on the adhesive flange and including at least one opening, the base connector being configured to cooperate with a device-side connector such that, through the cooperation of the device-side connector and the base connector, the base plate can be attached to and detached from the locator assembly, wherein, when the base plate is attached to the locator assembly, the at least one opening of the adhesive flange is aligned with the at least one opening of the base connector and a port sensor, such that the port sensor senses that aspect of the access port through the at least one opening of the adhesive flange and the at least one opening of the base connector.

[0061] In some respects, the technology described herein relates to a device in which the locator assembly further includes a skin sensor configured to sense proximity of the device to the skin via at least one opening of the adhesive flange and at least one opening of the base connector.

[0062] In some respects, the technology described herein relates to a device in which a skin sensor includes at least one spring-loaded needle.

[0063] In some respects, the technology described herein relates to a device that further includes: a skin sensor configured to sense proximity between the device and skin, wherein the skin sensor includes at least one spring needle, and wherein a base plate includes at least one through-hole for the spring needle to extend through it and sense contact with the skin of a living body.

[0064] In some respects, the technology described herein relates to a device in which a base connector is configured to cooperate with a connector of at least one drug delivery device.

[0065] In some respects, the technology described herein relates to a device in which the drug delivery device includes at least one of a needle assembly, an autoinjector, or a wearable injector.

[0066] In some respects, the technology described herein relates to a device in which the device-side connector and the base connector each have a cylindrical shape and are structured to cooperate threadedly with each other.

[0067] In some respects, the technology described herein relates to a device that further includes a marking device structured to be placed through an opening in a base plate for marking the skin.

[0068] In some respects, the technology described herein relates to a device that further includes a disinfecting swab structured to be placed through an opening in a base plate for disinfecting the skin.

[0069] In some respects, the technology described herein relates to a device in which: a base connector is made of a flexible material and includes a plurality of flexible fingers; and a device-side connector includes a protruding recess, wherein the plurality of flexible fingers and the protruding recess cooperate with each other to attach the base connector to and detach the base connector from the device-side connector.

[0070] In some respects, the technology described herein relates to a device in which the plurality of flexible fingers of the base connector are configured to cooperate with the buttress of the drug delivery device to restrict the removal of the drug delivery device from the base plate.

[0071] In some respects, the technology described herein relates to a device in which a controller is also configured to determine incompatibility between a baseboard and an access port based on sensed aspects of a port sensor, and wherein the feedback includes an indication of incompatibility.

[0072] In some respects, the technology described herein relates to a device in which a controller determines that a baseboard is incompatible based on the identified manufacturer of the access port.

[0073] In some respects, the technology described herein relates to a device in which the base connector is configured to work only with an access port manufactured by a predetermined manufacturer.

[0074] In some respects, the technology described herein relates to a device in which the underside of a locator assembly includes a port relief region to accommodate a protrusion of an access port beneath the skin.

[0075] In some respects, the technology described herein relates to a device in which: a locator assembly includes a plurality of skin sensors; and the at least one opening of the adhesive flange includes a plurality of openings respectively corresponding to the plurality of skin sensors so that the plurality of skin sensors pass through them to sense skin.

[0076] In some aspects, the technology described herein relates to a locator assembly for use with an access port implanted in a living organism, the locator assembly comprising: a port sensor configured to sense one aspect of the access port; a controller configured to determine the location of the access port based on the aspect sensed by the port sensor; and an output device configured to provide feedback to a user, wherein the controller is further configured to instruct the output device to provide feedback to the user based on the determined location of the access port, the locator assembly further comprising a housing in which the controller is located, the housing including a device-side connector configured to attach to and detach from a base connector of a base plate.

[0077] In some respects, the technology described herein relates to a locator assembly that further includes a skin sensor configured to sense the proximity of the locator assembly through at least one opening in a base plate.

[0078] In some respects, the technology described herein relates to a locator assembly in which the skin sensor includes at least one spring-loaded needle.

[0079] In some respects, the technology described herein relates to a positioner assembly in which the device-side connector has a cylindrical shape and is structured to thread with the base connector.

[0080] In some respects, the technology described herein relates to a positioner assembly in which the device-side connector includes a protruding groove.

[0081] In some respects, the technology described herein relates to a device for use with an access port implanted in a living organism, the device comprising: a base plate including: an adhesive flange; and a base connector located on the adhesive flange, the base connector including an opening and an attachment configuration for attaching and detaching with a plurality of components, the plurality of components including a locator assembly for positioning the access port.

[0082] In some respects, the technology described herein relates to a device in which the base connector includes a threaded connection surrounding an opening.

[0083] In some respects, the technology described herein relates to a device in which the attachment configuration includes a plurality of flexible fingers surrounding an opening.

[0084] In some respects, the technology described herein relates to an apparatus that further includes: a drug delivery device including a device connector having a protruding groove, wherein the plurality of flexible fingers of the attachment configuration interact with the protruding groove to attach a base connector of a base plate to the device connector of the drug delivery device and to detach the base connector from the device connector.

[0085] In some respects, the technology described herein relates to a device in which the device connector further includes a tapered support configured to insert into an opening in the base connector when the base plate is attached to the device connector and to prevent or resist inward bending of the plurality of flexible fingers, thereby preventing or resisting detachment of the base connector from the device connector.

[0086] In some respects, the technology described herein relates to a device in which the adhesive flange is made of a flexible material.

[0087] In some respects, the technology described herein relates to a device in which the base connector is made of a rigid material.

[0088] In some respects, the technology described herein relates to an apparatus in which a base connector and an adhesive flange are co-molded during manufacturing to produce a monolithic base plate.

[0089] In some respects, the technology described herein relates to a device in which the base connector is made of a flexible material.

[0090] In some respects, the technology described herein relates to a device in which an adhesive flange includes an adhesive layer and an adhesive backing, the adhesive layer being configured to adhere to the skin of a living body when the adhesive backing is removed.

[0091] In some respects, the technology described herein relates to an apparatus in which an adhesive backing is folded to form a top half that contacts the adhesive layer and a bottom half that includes a pull tab for removing the adhesive backing from the adhesive layer.

[0092] In some respects, the technology described herein relates to a device in which an adhesive flange comprising an adhesive layer and an adhesive backing includes at least one through-hole for a spring needle to extend through it and sense contact with the skin of a living body.

[0093] In some respects, the technology described herein relates to a device in which the adhesive flange includes an opening corresponding to the opening of the base connector.

[0094] In some respects, the technology described herein relates to a device in which a base plate includes a port relief region that is structured to accommodate a protrusion of an access port beneath the skin of a living organism.

[0095] In some aspects, the technology described herein relates to a method of accessing an implantable port in a living organism, the method comprising: positioning a base plate over the location of the access port, wherein the base plate includes: an adhesive flange; and a base connector located on the adhesive flange, the base connector including an opening and an attachment configuration for attaching and detaching with a plurality of components, the plurality of components including a locator assembly for determining the location of the access port; and adhering the base plate over the location of the access port such that the opening of the base connector corresponds to a puncturable elastomeric diaphragm of the access port.

[0096] In some respects, the technology described herein relates to a method in which the adhesion of a base plate further includes: removing an adhesive backing from an adhesive layer of the base plate, wherein the adhesive backing is folded to form a top half in contact with the adhesive layer and a bottom half including a pull tab for removing the adhesive backing from the adhesive layer.

[0097] In some respects, the techniques described herein relate to a method that also includes using a locator component to determine the location of an access port.

[0098] In some respects, the technology described herein relates to a method that further includes removing the base plate from the locator assembly after the base plate has been adhered.

[0099] In some respects, the technology described herein relates to a method in which at least one of the plurality of components is a drug delivery device, and the method further includes: a base connector for attaching the drug delivery device to a base plate.

[0100] In some aspects, the technology described herein relates to a method for administering at least one drug to a patient, the method comprising: determining the location of an access port under the patient's skin using a locator assembly of a device; adhering a base plate of the device to the patient's skin at a location corresponding to the location of the access port; detaching the locator assembly from a base connector of the base plate adhered to the skin; and administering a first drug to the patient through an opening in the base plate adhered to the skin.

[0101] In some respects, the technology described herein relates to a method in which administering a first drug to a patient further includes attaching a drug delivery device to a base connector, wherein the drug delivery device includes a support structured to protrude into an opening in the base plate and restrict detachment of the drug delivery device from the base connector.

[0102] In some respects, the technology described herein relates to a method in which administering a first drug to a patient further includes: attaching an autoinjector guide to a base connector; and using an autoinjector having the autoinjector guide to administer the first drug to the patient through an opening in the base plate.

[0103] In some respects, the techniques described herein relate to a method that further includes: replacing the needle of a syringe with an autoinjector needle to form an autoinjector prior to its use.

[0104] In some respects, the technology described herein relates to a method in which administering a first drug to a patient further includes: attaching an injection needle assembly to a base connector; and using the injection needle assembly to puncture the patient's skin via an opening and to puncture an elastomeric diaphragm of an access port, thereby positioning the injection needle assembly in fluid connection with the access port and administering the first drug to the patient therethrough.

[0105] In some respects, the technology described herein relates to a method in which administering a first drug to a patient further includes: attaching a wearable syringe to a base connector; and causing a protrusion of the needle of the wearable syringe to pierce the patient's skin through an opening and to pierce an elastomeric diaphragm of an access port, thereby positioning the wearable syringe in fluid connection with the access port and administering the first drug to the patient therethrough.

[0106] In some respects, the technology described herein relates to a method that further includes: adhering a second base plate to the patient's skin at a location adjacent to the location of the first base plate; and administering a second drug to the patient through an opening in the second base plate.

[0107] In some respects, the technology described herein relates to a method that further includes disinfecting the patient’s skin exposed by the opening of the base plate with a disinfectant swab before administering a first drug to the patient.

[0108] In some aspects, the technology described herein relates to a method for administering a drug to a patient, the method comprising: administering a first drug to the patient, including attaching a first drug administration device to a base plate adhered to the patient's skin; removing the first drug administration device from the base plate; administering a second drug to the patient, including attaching a second drug administration device to the base plate adhered to the patient's skin; removing the second drug administration device from the base plate; administering a third drug to the patient, including attaching a third drug administration device to the base plate adhered to the patient's skin; and removing the third drug administration device from the base plate, wherein the base plate includes an adhesive flange and a base connector located on the adhesive flange.

[0109] In some respects, the technology described herein relates to a method in which the first, second, and third drug application devices are different types of drug application devices.

[0110] In some respects, the technology described herein relates to a method in which at least one of a first, second, or third drug application device is attached to a base connector of a base plate, and at least one additional base connector of the first, second, or third drug application device is attached to a second base connector of the base plate.

[0111] In some respects, the technology described herein relates to a method that further includes administering a fourth drug to a patient, comprising attaching a fourth drug delivery device to a second base plate adhered to the patient's skin, wherein the second base plate is adjacent to a base plate on the patient's skin.

[0112] In some respects, the technology described herein relates to a method in which each of the first, second, and third drug application devices is of the same type.

[0113] In some respects, the technology described herein relates to a method in which the same type of drug delivery device is at least one of an autoinjector, a needle assembly, or a wearable injector.

[0114] In some respects, the technology described herein relates to a method in which the first, second, and third drugs comprise a treatment regimen for a patient's condition.

[0115] In some respects, the technology described herein relates to a method that further includes: determining the location of an access port beneath the patient's skin; and adhering a base plate to the patient's skin at a location corresponding to the access port location.

[0116] In some respects, the technology described herein relates to a method in which a base plate includes an opening extending through an adhesive flange and a base connector, and at least one of a first, second, or third drug is administered to a patient via the opening.

[0117] In some respects, the techniques described herein relate to a method in which at least one of a first, second, or third drug is administered subcutaneously to a patient.

[0118] In some aspects, the technology described herein relates to a device for use with an implantable access port in a living organism, the device comprising: a locator assembly including: a port sensor structured to sense one aspect of the implantable access port; a controller structured to detect the position of the implantable access port based on the aspect sensed by the port sensor; and an output device structured to provide feedback to a user, wherein the controller is further structured to instruct the output device to provide feedback to the user based on the detected position of the implantable access port.

[0119] In some respects, the technology described herein relates to a device in which the implanted access port is a subcutaneous access port.

[0120] In some respects, the technology described herein relates to a device in which an implantable access port is structured for subcutaneous or intravenous drug delivery.

[0121] In some respects, the technology described herein relates to a device that further includes a skin sensor structured to sense the proximity of the device to the skin, wherein a controller instructs the port sensor to sense this aspect based on the proximity of the device to the skin.

[0122] In some respects, the technology described herein relates to a device in which different material densities are incorporated into the implanted access port.

[0123] In some respects, the technology described herein relates to a device in which different material densities include the material density of the port housing of an implantable access port and the material density of the diaphragm of the implantable access port, wherein the port housing material is denser than the diaphragm material.

[0124] In some respects, the technology described herein relates to a device in which the feedback is at least one of tactile, visual, or auditory.

[0125] In some respects, the technology described herein relates to a device in which the skin sensor includes a skin sensor array and the port sensor includes a port sensor array.

[0126] In some respects, the technology described herein relates to a device in which the controller is also structured as at least one of a calibration port sensor or a skin sensor.

[0127] In some respects, the techniques described herein relate to a device in which the controller is also structured to remove anomalous data provided by at least one of a port sensor or a skin sensor.

[0128] In some respects, the technology described herein relates to a device in which: the controller is further structured to selectively engage at least one of a port sensor or a skin sensor at regularly spaced time intervals; and the regularly spaced time intervals are at least one of the following: constant, constructed based on the specific purpose of the device, or shortened or lengthened in response to proximity to an implantable access port or detection of material including the implantable access port.

[0129] In some respects, the technology described herein relates to a device in which: based on sensing at least one of a port sensor or a skin sensor, a controller is structured to detect or distinguish one or more materials constituting different elements of an implantable access port; and these elements include a port housing or an elastomer capable of piercing at least one of a port diaphragm.

[0130] In some respects, the technology described herein relates to a device in which a controller is also structured to identify one or more regions of an elastomeric puncture-resistant port diaphragm, and wherein each of these regions corresponds to a puncture-resistant diaphragm of a discrete lumen connected to an implantable access port.

[0131] In some respects, the technology described herein relates to a device in which: the controller and port sensor are also structured to identify an aspect of a puncturable elastomeric port diaphragm or port housing; and the aspect includes at least one of geometry, profile, or material.

[0132] In some respects, the technology described herein relates to a device in which the controller is also structured to identify at least one of the design, model, or manufacturer of the embedded access port based on this aspect of the port housing.

[0133] In some respects, the technology described herein relates to a device in which the controller is also structured to detect the orientation of an implantable access port under the skin based on sensing from at least one of a port sensor or a skin sensor.

[0134] In some respects, the technology described herein relates to a device in which the controller is also structured to detect an inverted orientation of the implantable access port beneath the skin based on determining the bottom-up orientation of the implantable access port toward the skin.

[0135] In some respects, the technology described herein relates to a device in which the controller is also structured to provide an alarm using a feedback element when the controller detects at least one of a desired, undesirable, or unsafe condition associated with at least one of the device, skin, or implanted access port.

[0136] In some respects, the technology described herein relates to a device in which the controller is also structured to provide feedback to individual input / output devices, such that the individual input / output devices provide feedback to the user in a more detailed format than the output devices.

[0137] In some respects, the technology described herein relates to a device in which: the feedback is directional feedback; and the controller is also structured to instruct the output device to provide directional feedback to the user, such that the directional feedback indicates the direction in which the device moves to locate the implanted access port.

[0138] In some respects, the technology described herein relates to a device in which directional feedback includes two-dimensional information about the direction of movement.

[0139] In some respects, the technology described herein relates to a device in which directional feedback is a vector representation corresponding to the direction of movement.

[0140] In some respects, the technology described herein relates to a device that further includes a housing in which a controller, a port sensor, and a skin sensor are located, and wherein the controller, port sensor, and skin sensor are structured to detect an implantable access port by distinguishing the more dense port housing of the implantable access port from the less dense port diaphragm of the implantable access port.

[0141] In some respects, the techniques described herein relate to a device in which a controller and a port sensor array are structured as the relative positions of a computing device with respect to one or more features of an embedded access port.

[0142] In some respects, the technology described herein relates to a device in which a controller and a port sensor array are structured to determine the relative position of the port sensor array with respect to an implanted access port when a user moves a device over the skin.

[0143] In some respects, the technology described herein relates to a device in which an output device provides feedback of the change when a controller detects a change in the relative position of the device with respect to an embedded access port.

[0144] In some respects, the technology described herein relates to a device in which a controller and a port sensor array are structured to infer that the device is near an implantable access port, but not directly above the elastomeric diaphragm of the implantable access port.

[0145] In some respects, the technology described herein relates to a device in which a controller and a port sensor array are structured to infer that the device is located directly above an elastomeric diaphragm of an implanted access port.

[0146] In some aspects, the technology described herein relates to a device that further includes: a positioner assembly, which also includes a housing in which a controller and a port sensor are located, the housing including a device-side connector; a base plate including an adhesive flange; and a base connector attached to the base plate, wherein the device-side connector and the base connector are structured to cooperate with each other; and wherein the positioner assembly and the base plate are removably connected via the cooperation of the device-side connector and the base connector.

[0147] In some respects, the technology described herein relates to a device in which a base connector is structured to cooperate with a connector of one or more medical application components.

[0148] In some respects, the technology described herein relates to a device in which the device-side connector and the base connector each have a cylindrical shape and are structured to cooperate threadedly with each other.

[0149] In some respects, the technology described herein relates to a device in which the base connector is structured as a puncturable elastomeric portion corresponding to the implantable access port when the device is positioned directly above the implantable access port.

[0150] In some respects, the technology described herein relates to a device in which the one or more medical application components include a drug delivery device.

[0151] In some respects, the technology described herein relates to a device in which the drug delivery device includes at least one of a needle assembly, an autoinjector, or a wearable injector.

[0152] In some respects, the technology described herein relates to a device that further includes a base plate comprising an opening structured to correspond to a punctureable elastomeric portion of an implantable access port.

[0153] In some respects, the technology described herein relates to a device in which an opening is structured to provide access to a puncturable elastomeric portion of an implantable access port using a drug delivery device.

[0154] In some respects, the technology described herein relates to a device in which a base connector is structured to attach to a drug delivery device.

[0155] In some respects, the technology described herein relates to a device in which a drug delivery device is accessed through a puncturable elastomeric portion of an implantable access port, without being attached to a base connector.

[0156] In some respects, the technology described herein relates to a device in which the base connector is selected based on the drug delivery device.

[0157] In some respects, the technology described herein relates to a device in which an opening is structured to allow insertion of a component having a shape corresponding to the shape of the opening.

[0158] In some respects, the technology described herein relates to a device in which the component performs at least one of the following: preparing the skin, disinfecting the skin, or marking the skin.

[0159] In some respects, the technology described herein relates to a device that further includes: the one or more medical application components.

[0160] In some respects, the technology described herein relates to a device that further includes a marking device structured to be placed through an opening in a base plate for marking the skin.

[0161] In some respects, the technology described herein relates to a device that further includes a disinfecting swab structured to be placed through an opening in a base plate for disinfecting the skin.

[0162] In some aspects, the technology described herein relates to a method for administering a drug to a patient, the method comprising: using a device to locate an implantable access port under the skin of a patient, the device including a base plate and a locator assembly having sensors, a controller, and output devices; adhering the base plate to the patient's skin over the implantable access port; removing the locator assembly from the base plate by disconnecting a device-side connector included in the locator assembly from a base-side connector included in the base plate; attaching a drug delivery device to the base-side connector such that the drug delivery device is positioned over an opening in the base plate to access the implantable access port under the patient's skin; and administering the drug to the patient through the implantable access port using the drug delivery device.

[0163] In some respects, the technology described herein relates to a method in which a drug delivery device includes an injection needle assembly, an implantable access port includes an elastomeric diaphragm, and administering the drug to a patient further includes: puncturing the patient’s skin and elastomeric diaphragm with a needle included in the injection needle assembly, thereby positioning the injection needle assembly in fluid communication with the implantable access port.

[0164] In some respects, the technology described herein relates to a method in which a drug delivery device is attached to a base-side connector to unlock an injection needle to allow the needle to be advanced into the patient's skin.

[0165] In some respects, the technology described herein relates to a method in which the drug delivery device is a wearable syringe, and the method further includes: removing an adhesive from the wearable syringe; providing a connector on the wearable syringe; and attaching the wearable syringe to a base plate using the connector on the wearable syringe and a base-side connector.

[0166] In some respects, the technology described herein relates to a method in which the drug delivery device is structured as a handheld autoinjector for use with an autoinjector guide.

[0167] In some respects, the technology described herein relates to a method in which attaching a drug delivery device to a base-side connector further includes attaching an autoinjector guide to the base-side connector.

[0168] In some respects, the technology described herein relates to a method in which administering a drug to a patient further includes: inserting a handheld autoinjector into an autoinjector guide to position the needle on the skin exposed by an opening in the base plate; and puncturing the patient's skin with the needle of the handheld autoinjector, thereby positioning the handheld autoinjector in fluid communication with an implantable access port.

[0169] All documents mentioned herein are hereby incorporated in their entirety by reference. Unless otherwise expressly stated or clear from the text, references to singular items shall be understood to include plural items, and vice versa. Unless otherwise stated or clear from the text, grammatical conjunctions are intended to express any and all antonymous conjunctions and combinations of conjunctions relating terms, sentences, words, etc. Attached Figure Description

[0170] The following detailed description of this disclosure and some embodiments thereof can be understood with reference to the following figures.

[0171] Figure 1AA simplified partial sectional front view is shown, illustrating the anatomical location of the patient interface component for intravenous drug delivery using an example implantable vascular access port.

[0172] Figure 1A-1 and Figure 1A-2 This is a cross-sectional view of an example of intravenous drug delivery using an implantable vascular access port in a patient, according to an example embodiment.

[0173] Figure 1B A simplified partial cross-sectional view of the anatomical location of an example implantable vascular access port is shown.

[0174] Figure 1C-1 and Figure 1C-2 These are perspective views of example implantable vascular access devices with single-lumen and double-lumen configurations, respectively.

[0175] Figure 2 This is a schematic block diagram of a port positioning component, part, and sensor according to an example embodiment.

[0176] Figure 3A This is a schematic block diagram of a positioning component for locating an implanted access port according to an example embodiment.

[0177] Figure 3B , Figure 3C and Figure 3D These are respectively used according to the example embodiments for... Figure 3A Top view sectional illustration of the first, second and third states in the method of locating the implantation port using the positioning component.

[0178] Figure 3E A simplified frontal sectional view is shown, illustrating the anatomical orientation of the inverted access port implanted beneath the patient's skin.

[0179] Figure 3F The example embodiment illustrates how to use Figure 3A A top-view cross-sectional view of a sensor configuration used by a device to detect an inverted implanted port.

[0180] Figure 4A-1 , Figure 4A-2 and Figure 4A-3 An exploded perspective view, a top view, and a bottom view of the positioning component according to an example embodiment are illustrated.

[0181] Figure 4A-4A and Figures 4A-4B The illustration shows crossing Figure 4A-2 The sectional views taken from 4A-4A and 4A-4B show cross-sections of the positioning component according to the example embodiment.

[0182] Figures 4A-5A and Figure 4A-5B The illustration shows crossing Figure 4A-2 The sectional views taken from 4A-4A and 4A-4B show cross-sections of the positioning component according to the example embodiment.

[0183] Figure 4B-1 and Figure 4B-2 The illustration shows a perspective view of a handheld positioning component according to an example embodiment.

[0184] Figure 4C-1A , Figure 4C-1B , Figure 4C-2A , Figure 4C-2B , Figure 4C-2C , Figure 4C-3A and Figure 4C-3B The illustration shows a top view of a positioning component with various orientation and position feedback changes according to an example embodiment.

[0185] Figure 4D-1 , Figure 4D-2 , Figure 4E-1 , Figure 4E-2 and Figure 4F The illustration shows a cross-sectional view of a positioning component related to the skin and implantable access port according to an example embodiment.

[0186] Figure 5A This is an exploded assembly diagram of the components of a port positioning assembly included in a housing of a port positioning device, according to an example embodiment.

[0187] Figure 5B This is a partial side sectional view of a component in a port positioning device, which is also assembled and shown in relation to an implanted port, both according to an example embodiment.

[0188] Figures 5C-1 to 5C-4 This is a partial top view of the base plate according to an example embodiment.

[0189] Figures 5D-1 to 5D-3 These are perspective views of a port positioning device shown in three progressive removal phases following the location of the implanted port, according to an example embodiment.

[0190] Figure 5E The illustration shows a cross-sectional view of a base plate relating to skin and an implantable access port according to an example embodiment.

[0191] Figure 5F The illustration shows a cross-sectional view of a base plate and a drug delivery device in relation to skin and an implantable access port according to an example embodiment.

[0192] Figure 5G The illustration shows a cross-sectional view of a base plate and a drug delivery device in relation to skin and an implantable access port according to an example embodiment.

[0193] Figure 5H-1 This is a bottom view of a base plate having an adhesive layer and an adhesive backing according to an example embodiment.

[0194] Figure 5H-2 This is a cross-sectional view of the adhesive layer and adhesive backing according to an example embodiment.

[0195] Figure 6A-1 and Figure 6A-2 This is a partial cross-sectional view of the skin disinfection or preparation steps combined with the base plate, all according to the example embodiment.

[0196] Figure 6B-1 and Figure 6B-2 This is a partial cross-sectional view of the skin marking steps for locating the implantation port using the base plate, all based on the example embodiment.

[0197] Figure 6C This is a top view of the marked skin with the base plate indicating the location of the implantation port, all according to the example embodiment.

[0198] Figure 7A The illustration shows a perspective view of a pin assembly for use with a base plate according to an example embodiment.

[0199] Figures 7B-1 to 7B-3 The illustration shows a perspective view of a needle assembly shown in relation to the implantation port, all according to an example embodiment.

[0200] Figures 7C-1 to 7C-2 This is a cross-sectional view of the needle assembly related to the implantation port, illustrating the insertion of the drug delivery needle into the implantation port, all according to the example embodiment.

[0201] Figure 8A This is a perspective view of a wearable syringe based on related technologies.

[0202] Figure 8B-1 , Figure 8B-2 and Figure 8B-3 This is a perspective view of a wearable syringe for use with a fixed base plate, according to an example embodiment.

[0203] Figure 8C-1 and Figure 8C-2 This is a partial sectional view of a wearable syringe relative to the base plate fixed on the implantable access port, all according to the example embodiment.

[0204] Figure 8D-1A and Figure 8D-2 This is a cross-sectional view of a wearable syringe mounted on a base plate before and during drug delivery to the implantable access port. Figure 8D-1B yes Figure 8D-1A A close-up view of a portion of the example embodiment, all based on the example embodiment.

[0205] Figure 9A This is a perspective partial sectional view showing the relationship between the autoinjector and the base plate fixed on the implantable access port, all according to the example embodiment.

[0206] Figure 9B This is a cross-sectional side view showing the relationship between the autoinjector and the base plate fixed on the implantable access port, all according to the example embodiment.

[0207] Figure 9C and Figure 9D This is a perspective view showing the assembly of an autoinjector adapter in relation to a base plate fixed on an implantable access port, all according to an example embodiment.

[0208] Figure 9E-1 and Figure 9F-1 This is a partial sectional view of an autoinjector related to the base plate fixed on the implantable access port, all according to the example embodiment.

[0209] Figure 9E-2 and Figure 9F-2 This is a sectional side view showing the assembly of the device adapter via an autoinjector to the base plate secured above the implantable access port and subsequent drug delivery, all according to the example embodiment.

[0210] Figure 9G This is a cross-sectional side view of an autoinjector mounted on a base plate during drug delivery to an implantable access port, all according to an example embodiment.

[0211] Figure 10 The illustration shows a flowchart of an example method for locating an access port implanted in a living organism, according to an example embodiment.

[0212] Figure 11 The illustration shows a flowchart of an example method for using an access port under the skin of an implanted living organism, according to an example embodiment.

[0213] Figure 12 The illustration shows a flowchart of an example method for accessing an access port implanted in a living organism according to an example embodiment.

[0214] Figure 13 A flowchart illustrating an example method for administering at least one drug to a patient according to an example embodiment is shown.

[0215] Figure 14 The illustration shows a flowchart of an example method for administering a drug to a patient according to an example embodiment. Detailed Implementation

[0216] To clearly, concisely, and accurately describe the non-limiting exemplary embodiments of this disclosure, the ways and processes of making and using these embodiments, and to enable the practice, making, and using of these embodiments, reference will now be made to certain exemplary embodiments (including the exemplary embodiments illustrated in the accompanying drawings), and these embodiments will be described using specific language. Nevertheless, it should be understood that this does not constitute a limitation on the scope of this disclosure, and that this disclosure includes and protects such variations, modifications, and further applications of the exemplary embodiments as would be conceived by those skilled in the art benefiting from this disclosure.

[0217] Example access port Figures 1A to 1C-2 An example implantable intravenous access port that may be involved in an example embodiment of this disclosure is shown. Figure 1A A simplified partial sectional front view is shown, illustrating the anatomical location of the patient interface components for intravenous drug delivery using an example implantable vascular access device or "access port" 130 and a port access needle (e.g., a hollow-hole percutaneous needle with a curved cannula and a deflected sharp end, such as a Huber needle). Figure 1A-1 and Figure 1A-2 This is a partial cross-sectional view (also referred to herein as a cross-sectional view) of intravenous drug delivery using an implantable vascular access device or port and port access needle 124 (possibly fluidly connected to a drug delivery tube 122) according to an example embodiment. Figure 1B A simplified partial cross-sectional view of the anatomical location of an example implantable vascular access device or access port is shown. Figure 1C-1 and Figure 1C-2 This is a perspective view of an example implantable vascular access device with single-lumen and double-lumen configurations.

[0218] This disclosure is not limited to the example port designs and variations described herein. Although Figure 1A-1C-2 The intravenous access port 130 is illustrated by way of example, but in some embodiments, the access port may include any implantable port for drug delivery by any physiological route, such as subcutaneous (SC), intravenous (IV), intrathecal, or other routes. The exemplary embodiments of this disclosure can be used with access ports that are intended for any physiological administration route, have any port housing design, any number of diaphragms, or any other ancillary features or availability.

[0219] A description of the components and aspects of an example access port is presented to explain more fully how the example embodiments of this disclosure can be advantageously used with various access port designs.

[0220] In an example embodiment, the intravenous access port 130 may be an access port implanted under the skin of a patient (e.g., a living organism, which may be a human or other animal or living organism), wherein "skin" may include the skin and any tissue beneath which the access port is implanted, such as subcutaneous tissue. Thus, in the example embodiment involving the intravenous access port, the port may be implanted under the patient's skin and subcutaneous tissue. Other types of ports may be implanted in different ways.

[0221] The implantable access port 130 may include a port housing 127 defining a cavity 126c that encloses one or more port diaphragms 126. The cavity 126c is fluidly connectable to one or more catheters 128 (e.g., single-lumen catheters). The implantable access port 130 can be surgically placed in a subcutaneous space beneath the skin 123 of a patient 121, where the patient's skin 123 acts as a natural barrier against microorganisms or other contaminants. As described above, the skin 123 of the patient 121 may include the skin itself and any underlying tissue, such as subcutaneous tissue, under which the access port 130 is implanted. In IV access ports (such as...), Figure 1A-1 In the case of example access port 130 in C), catheter 128 can be positioned during implantation to be in fluid communication (also referred to as fluid connection) with one aspect of the patient’s venous system (e.g., superior vena cava 109).

[0222] The port housing 127 may be made of a metal (such as medical-grade stainless steel, titanium) or a polymer with or without radiopaque additives. The port diaphragm 126 may be made of an elastomeric material (such as silicone) and is selected and designed to self-seal during and after insertion of a specially designed access pin and after removal of the access pin. Figure 1C-2 As illustrated in the examples, in addition to the previously described single-lumen port, one or more of the port 130, port cavity 126c, or diaphragm 126 may be divided into two or more distinct regions, each individually attached to the catheter 128 or double-lumen catheter 136, thereby providing fluid-independent communication to the superior vena cava 109, which may be desirable for a particular drug or drug regimen. For example, as Figure 1C-2 As illustrated, the port housing 131 can divide the diaphragm into a first port diaphragm 133 and a second port diaphragm 134, wherein the first needle inlet 132 is located in the first port diaphragm 133 and the second needle inlet 135 is located in the second port diaphragm 134.

[0223] One or more of the port housing, diaphragm, or conduit may be designed to withstand a variety of injection pressures and may also have other features such as identification markings or shapes, palpable bumps, retention rings or collars, or other components.

[0224] Example locator component - controller Now for reference Figure 2 In an example embodiment, the port positioning component 200 may be disposed within the housing 210. This port positioning component includes one or more port position sensors 204, one or more skin sensors 205, and one or more input / output devices, any or all of which may be connected to the controller 201. The controller 201 may include a processor 202 connected to the memory 203, and input / output devices 206. These components are... Figure 2 The various structural forms that these components may take are illustrated in block form, and will be described in detail below in one or more example embodiments. Other structural forms will be apparent to those skilled in the art in light of the teachings herein.

[0225] Support circuitry may be provided to controller 201 to provide communication between different components of the system, including port position sensor 204 and skin sensor 205, as described in the example embodiments herein. The support circuitry may also include amplifiers or signal conditioning circuitry inserted between the port position sensor and the controller, or between one or more input / output devices and the controller. Controller 201 may also include support circuitry for providing power to the different components of the system, and power switches configured to supply or interrupt power to controller 201 and / or port positioning assembly 200.

[0226] The controller 201 and other components of the port positioning assembly 200 may be powered by internal or external means, such as batteries, inductive coupling, external cabling, kinetic motion, kinetic energy harvesting, or other power sources. In some embodiments, due to the availability of battery materials (such as lithium-ion or nickel-metal hydride batteries) and / or environmental influences, and such as when the port positioning assembly 200 is designed to be disposable, the port positioning assembly 200 and its power source may be designed to use (e.g., through careful power management and / or low power consumption) disposable batteries (such as alkaline batteries (e.g., AA or AAA cell batteries)) because such batteries can be disposed of as ordinary waste. In fact, example embodiments may use disposable batteries through various power management techniques, such as those described herein regarding sensor sampling rates, and some example embodiments of the device itself may be disposable. However, embodiments are not limited thereto, and in some embodiments, the power source may be designed to use rechargeable batteries (e.g., lithium-ion or nickel-metal hydride batteries), such as, but not limited to, examples where the device including the port positioning assembly 200 is designed to be reusable.

[0227] Memory 203 may include any volatile or non-volatile media, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, etc. Memory 203 may include separate memory portions for storing instructions, device serialization or unique device identifier (UDI) data, batch number or expiration information, data corresponding to different implantable ports for device location, data corresponding to different materials used to construct implantable ports (e.g., implantable access port 130), patient information, or other data that may benefit from a separate memory module.

[0228] In an example embodiment, memory 203 may be a non-transitory computer-readable storage medium storing instructions for execution by, for example, processor 202. In an example embodiment, processes for operating a system may be stored in memory 203. For example, these processes may be stored in memory 203 as software routines that, when executed by processor 202, cause the system to perform methods according to example embodiments described in this disclosure. In an example embodiment, some or all of the processes for operating a system may be executed in hardware. In an example embodiment, the processes for operating a system may be executed by processor 202, which may include one or more processors, including one or more microprocessors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), software-on-a-chip (SOC), or integrated circuit (IC) components. A processor may generally refer to other logic circuit systems or equivalent circuit systems; alternatively, a processor may be provided by a hardware device and embodied as software, firmware, hardware, or any combination thereof. In an example embodiment, the software routines for operating a system may also be stored and / or executed by a second processor located remotely from the hardware controlled by the processor. In some embodiments, the second processor may include a cloud computing service, a cloud server, or a mobile computing device. Mobile computing devices can be any of a variety of suitable computing devices, such as smartphones, tablets, wearables, smartwatches, fitness trackers, laptops or desktops, or other suitable computing devices.

[0229] Any or all of the port sensor 204, skin sensor 205, and input / output device 206 may be connected to the controller 201 via a wired connection, a wireless connection, or a combination thereof. Wireless connections may include, for example, Bluetooth, Bluetooth Low Energy (BLE), WiFi, cellular, ZigBee, Near Field Communication (NFC), ultrasonic communication, infrared communication, other suitable RF connection technologies, or other wireless connection technologies. Wired connections may include, for example, Universal Serial Bus (USB), serial connections, I2C connections, Ethernet connections, other wiring, or other structured cable cabling.

[0230] One or more input / output devices 206 may include a network controller or an interface to a remote computer system. The network interface may be the Internet, an intranet, a local area network (LAN), a wide area network (WAN), a virtual private network (VPN), a wireless network, a cellular data network, or a combination thereof. In an example embodiment, when the network interface is unavailable (e.g., in the absence of an intranet, the Internet, cellular, Bluetooth, Zigbee, WiFi, or other signal), the controller 201 and memory 203 may locally store one or more inputs from sensors or input / output devices.

[0231] In some embodiments, the input / output device 206 may include visual, tactile (e.g., vibration) or auditory signals displayed or presented on a smartwatch or smartphone display, which is also connected to the controller 201 via the previously described connector.

[0232] Example locator component - sensor In an example embodiment, at least one of the port position sensors 204 may be configured to provide the controller 201 with data regarding one aspect of the access port 130 implanted beneath the skin 123 of the patient 121. In an example embodiment, at least one of the skin sensors 205 may be configured to provide the controller 201 with data regarding one aspect of the port positioning component 200 relating to the skin 123 of the patient 121.

[0233] The example embodiments described herein may describe positioning, such as positioning an implantation port, which may include one or more of the following operations: identifying port components, distinguishing one port component from another, identifying a port near a device, identifying the distance between one aspect of the port and the device, positioning the outer shell of the implantation port under the patient's skin, positioning the puncturable elastomeric diaphragm of the implantation port under the patient's skin, or calculating a two-dimensional or three-dimensional vector between the port and / or the port diaphragm and the device, each of the foregoing operations being performed according to the different example embodiments described herein.

[0234] While the exemplary embodiments described herein may be referred to in relation to positioning implantation ports (such as subcutaneous access ports), the embodiments are not limited thereto. For example, some embodiments herein may be applied to locate any foreign body located under the skin of a living organism (human or animal). In some examples, such as with subcutaneous access ports, the foreign body may be fluidly connected to the body, but the embodiments are not limited thereto.

[0235] In some embodiments, sensors 204 and 205 may be or include individual sensors or sensor arrangements, as illustrated by port sensor array 207 and skin sensor array 208. For example, one or more sensors 204 (which may be or include port sensor array 207) may be used to sense one aspect of port 130, and one or more sensors 205 (which may be or include skin sensor array 208) may be used to sense one aspect of skin 123. In some embodiments, one or more of sensors 204 or 205 may include capacitive, inductive, ultrasonic, magnetic, optical, radio frequency, thermal, thermopile, infrared, or other sensors, or combinations thereof. In an example, skin sensor 205 may include capacitive sensing or current sensing. In an example where skin sensor 205 includes capacitive sensing, capacitive sensing may detect an increase in capacitance when skin sensor 205 is near skin. In an example where skin sensor 205 includes current sensing, current sensing may detect a decrease in resistance (e.g., compared to air) when skin sensor 205 is near skin.

[0236] Depending on the clinical application, the intended implantation port(s) to be located by the device, the end user using the device, the desired sensor sampling rate, or other relevant factors, the port sensor 204 and skin sensor 205 can be selected, combined, and constructed in different ways. In some embodiments, an amplifier or signal conditioning circuit may be interposed between one or more of the port position sensor(s) 204, one or more of the skin sensors 205, the port sensor array 207, the skin sensor array 208, the input / output device 206, and / or the controller 201.

[0237] In some embodiments, one or more of sensors 204 or 205 may include electronically spring-loaded normally open or normally closed switches (e.g., where the switch itself involves a mechanical component) provided in the form of one or more spring-loaded pins, which may also be colloquially referred to as "spring pins". "Spring pins" can be very reliable and can have a sufficiently short pin travel so that they are unlikely to be "half-traveled" activated—instead, they are likely to be in an open or closed state. Therefore, some embodiments may include a port positioning assembly 200 having one or more spring pins serving as skin sensors 205, and each spring pin may utilize an open or closed signal to indicate whether it is in contact with the skin. In an example embodiment of a skin sensor 205 including a normally open spring pin, the spring pin can provide a signal (and thus draw power) when it is in contact with the skin and thus pressed. In an example embodiment of a skin sensor 205 including a normally closed spring pin, the spring pin can provide a signal (and thus draw power) when it is not in contact with the skin or is otherwise pressed.

[0238] In some embodiments, all or part of the spring pins may be made of plastic or other non-magnetic materials to reduce the electromagnetic interference (EMI) they generate.

[0239] In some embodiments, the port positioning component 200 may include a skin sensor 205 (including, for example, a skin sensor array 208) having one or more capacitive sensors. Parameters of the one or more capacitive sensors may include the number of antennas, the shape of the antennas, and the number of sensors. For example, some embodiments may include a matrix of capacitive sensors with a rejection algorithm regarding false positives. For example, in a matrix of four capacitive sensors, a rejection algorithm (e.g., on controller 201) that determines that sensing three of the four capacitive sensors in contact with and / or near the skin provides an accurate indication that the port positioning component 200 is indeed in contact with and / or near the skin.

[0240] In some embodiments, the port positioning component 200 may include a port sensor 204 (including, for example, a port sensor array 207) having one or more capacitive sensors, the one or more capacitive sensors having parameters and operation similar to the matrix described above for the skin sensor 205, but used to sense one aspect of the access port rather than the skin.

[0241] In some embodiments, in addition to being used as a skin contact sensor and / or instead of a skin contact sensor, a capacitive sensor can also be used as a skin proximity sensor. For example, in some embodiments, a capacitive sensor may be used first to detect proximity to the skin, and then a spring pin may be used to detect explicit contact with the skin. Regarding the detection of proximity, this proximity may be, for example, along a Z-axis relative to the skin (e.g., orthogonal to the skin), and the capacitive sensor may indicate a gradually increasing proximity as the port positioning assembly 200 moves closer. Furthermore, in some embodiments where one or more spring pins of the skin sensor 205 are normally closed (e.g., normally closed), these spring pins may typically draw power until they contact the skin. Thus, the port positioning assembly 200 (e.g., as controlled by the controller 201) may (e.g., by controlling the power supply via a latch or switch) not supply power to the spring pins to sense contact with the skin until the capacitive sensor(s) indicates that the port positioning assembly 200 is sufficiently close to the skin, thereby providing a power saving advantage. For example, controller 201 may not supply power to one or more spring pins until one or more capacitive sensors indicate that the positioning component is within the expected height of the protrusion under the skin at the access port. This feature provides improved power management to limit the power consumed by the port positioning component 200 and may allow the positioning component 200 to be powered by a disposable (e.g., alkaline) battery.

[0242] In some embodiments, when the skin sensor 205 indicates increasing proximity to the skin (e.g., along the Z-axis), the controller 201 may increase the sampling rate of either the port sensor 204 and / or the skin sensor 205 to improve detection accuracy. Similarly, as the skin sensor 205 indicates decreasing proximity to the skin, the sampling rate may be decreased. This feature provides improved power management while maintaining desired accuracy.

[0243] In some embodiments, the controller 201 and memory 203 may be provided with sensor profiles associated with one or more of the sensors 204 or 205 or the arrays 207 or 208. During one or more aspects of use, the controller 201 may use the data contained in the sensor profiles during operation of the device. For example, the sensor profiles may contain data corresponding to one or more types of sensors(s) provided in the device, calibration data of one or more sensors 204 or 205, sensors to be engaged by the controller 201 at various stages of operation, sensors to be engaged or disengaged when the controller 201 detects a certain condition, engagement intervals or sampling rates of sensors 204 or 205, sensor error correction data, or data corresponding to one or more sensors used under different conditions.

[0244] In some embodiments, one or more of the housing 210, sensors 204 or 205, one of the input / output devices 206, or one or more of the support circuitry (which connects sensors 204, 205, array 207 or 208, and input / output devices 206 to controller 201) may be provided with shielding elements to prevent interference (e.g., electromagnetic interference or EMI), signal distortion, or spurious signals from the component (e.g., movement from internal plastic or metal parts within the component), placing a hand on or near the positioning component 200, movement of the positioning component 200 by the user's hand, contact between the positioning component 200 and skin, or external interference (such as from radio frequency energy, "noise" from other electronic devices, or other energy sources). In some embodiments, one of the input / output devices 206 may include a sensor for detecting when the positioning component is in the user's hand, thereby enabling controller 201 to detect, control, or correct spurious signals from sensors 204 or 205 and / or array 207 or 208 caused by the user's hand on the device. In some embodiments (such as those including capacitive sensors), the device (e.g., the positioning assembly 200 or base plate as described herein) may include structures such as side flanges or lips surrounding the capacitive sensor to avoid misreading caused by a user gripping the port positioning assembly 200 (e.g., by a finger dangling along the underside of the port positioning assembly 200 and / or contacting the capacitive sensor and interfering with its sensing). For example, such a structure prevents the user's finger from covering or getting too close to the capacitive sensor.

[0245] Shielding elements may include, for example, ferrite beads, ferrite plates or sheets, metal foils or meshes, or other suitable shielding materials. Sensors 204 or 205 may be shielded individually or as part of a device subassembly. For example, in an example embodiment including both a capacitive sensor and a spring pin, the spring pin and / or capacitive sensor may be shielded (e.g., using a shielding element) to prevent electromagnetic interference generated by the mechanical movement of the spring pin from affecting the capacitive sensor. The size and shape of the shielding element may be selected based on the type of sensor chosen, the placement of sensor 204 or 205, the presence and nature of input / output device 206, the configuration and materials in housing 210 (if provided), the nature of the expected interference, and the desired sensitivity and accuracy of sensor 204 or 205. As an alternative to or supplement to shielding sensor 204 or 205 or housing 210, a support circuitry may be incorporated within the sensor itself (rather than controller 201 or input / output device 206) to generate digital signals directly at the sensor, which reduces the impact of interference or spurious signals on the analog signals provided to controller 201. Similarly, the supporting circuitry in one or more of the sensors 204 or 205, the controller 201, or the input / output device 206 can compensate for spurious signals caused by temperature variations that may affect the accuracy of the sensors.

[0246] The positioning component 200 may also be supplemented with one or more sensors in addition to sensors 204, 205 and / or arrays 207, 208. Such sensors may be configured as input / output devices 206 connected to the controller 201.

[0247] Port sensor array In some embodiments, sensors 204 and 205 may be arranged as one or more structured sensor networks or sensor arrays. Such a structured array can simplify device manufacturing, allow for the localization of a wide variety of port configurations, improve the accuracy or precision of port localization, or provide enhanced feedback to the user of the device regarding port localization. In some embodiments, the structure and / or configuration of the sensors may correspond to one aspect of an implanted port to be detected by the device to be used.

[0248] In an example embodiment, one or more port position sensors 204 may be combined to form a port sensor array 207, which may include multiple sensors (e.g., 207a, 207b, 207c, 207d, 207e). In some embodiments, the one or more port sensor arrays 207 may individually or in combination provide data to the controller 201 to locate one aspect of the access port 130 beneath the skin 123 of the implanted patient 121. Furthermore, in an example embodiment, one or more skin position sensors 205 may be combined to form a skin sensor array 208 including multiple sensors (e.g., 208a, 208b, 208c, 208d, 208e). In some embodiments, the one or more skin sensor arrays 208 may individually or in combination provide data to the controller 201 corresponding to one aspect of the skin 123 of the patient 121 having the implanted access port 130. In some embodiments, skin sensors (e.g., skin sensors 308a, 308b, 308c, 308d) may be concentric with peripheral port position sensors (e.g., peripheral port position sensors 307a, 307b, 307c, 307d), and / or the peripheral port position sensors may be located peripherally outside the skin sensors relative to a center, such as that indicated by the central sensor 307e. In some embodiments, the central sensor 307e may be a port position sensor, although embodiments are not limited thereto, and in some embodiments, the central sensor 307e may be a skin sensor. In some embodiments, the peripheral port position sensors 307a, 307b, 307c, 307d may be arranged in a concentric pattern around the central sensor 307e.

[0249] The foregoing descriptions and variations relating to one or more of sensors 204 and 205 may also apply to sensors 204 and 205 (when they are or include corresponding arrays 207 and 208). Therefore, as with port sensor 204 and skin sensor 205, port sensor array 207 and skin sensor array 208 may be selected, combined, and constructed in different ways depending on the clinical application, the intended implantation port(s) to be located by the device to be used, the end user using the device, the desired sensor sampling rate, the capabilities of controller 201 and supporting circuitry, or other relevant factors.

[0250] For the purposes illustrated herein, the port sensor array 207 (which may be configured to detect aspects of access port 130) and the skin sensor array 208 (which may be configured to detect aspects of skin 123) may be different arrays. However, embodiments are not limited thereto. In some embodiments, the sensor array may comprise any number of sensors 204 and 205 in any desired combination and arrangement. In some embodiments, either or both of the port sensor array 207 or the skin sensor array 208 may comprise a structured network of one or more sensors 204 and 205, and combinations and arrangements thereof.

[0251] The sensor arrays described herein can be used for a single purpose (regarding detecting only one aspect of port 130 or one aspect of skin 123), but embodiments are not limited thereto. For example, in some embodiments, the function performed by port sensor array 207 may be performed entirely or partially by skin sensor array 208. In some embodiments, the function performed by skin sensor array 208 may be performed entirely or partially by port sensor array 207. In some embodiments, either or both of port sensor array 207 and skin sensor array 208, or one or more sensors included in arrays 207, 208, may be used to sense one aspect of both port 130 and skin 123.

[0252] In an example embodiment, the port positioning component 200 may include one or more port sensor arrays 207 and / or one or more skin sensor arrays 208. This configuration allows for the selection of different sensors based on various states of the device or various steps of device use. For example, the controller 201 may receive data from a first set of skin sensor arrays 208 configured to operate when the component is in contact with the skin 123, from a second set of skin sensor arrays 208 when the component is not in contact with the skin 123, or from a combination of both the first and second sets when the component is near (but has not yet contacted) the skin 123.

[0253] Alternatively, in some embodiments, the controller 201 may receive data from a first set of port sensor arrays 207 configured to operate when the housing is near the positioned implantation port, from a second set of port sensor arrays 207 when the housing is not near the positioned implantation port, or from a combination of both the first and second port sensor arrays. In the foregoing examples, the controller 201 may also optionally be configured to receive data from either or both of the port sensor 204 or the skin sensor 205 during use of either the skin sensor array or the port sensor array.

[0254] Use of sensors In some embodiments, controller 201 may perform a calibration process for one or more of sensors 204, 205, port sensor array 207, or skin sensor array 208 to ensure that controller 201 receives correct data, corrects the data received by controller 201 for the usage environment, or avoids interference (e.g., from other sensors). In some embodiments, controller 201 may be configured to remove anomalous data provided by one or more of sensors 204, 205, port sensor array 207, or skin sensor array 208. In an example embodiment, controller 201 may be configured to receive and compare data from one or more sensors 204, 205, 207, 208 and discard or ignore anomalous data.

[0255] In an example embodiment, sensors 204, 205, port sensor array 207, or skin sensor array 208 may be selectively engaged by controller 201 at one or more regularly spaced intervals (e.g., energized, sampled, polled, or interrogated). The regularly spaced intervals may remain constant throughout the use of the device (e.g., 500 Hz for capacitive sensors), may be configured with multiple regularly spaced intervals based on specific steps of device use (e.g., 200 Hz for capacitive sensors initially further from the skin, then 500 Hz for capacitive sensors as proximity to the skin increases), or may shorten or lengthen the regularly spaced intervals in response to proximity to the port or detection of one or more materials constituting the port (e.g., 500 Hz initially further from the port, then gradually increasing with proximity to the port, for a fixed higher frequency or an increasing range, e.g., between 750 Hz and 1000 Hz, including the endpoints).

[0256] For example, in some embodiments, sensors 204, 205, port sensor array 207, or skin sensor array 208 may engage at a lower frequency (e.g., 500 Hz for a capacitive sensor, which can be described as a slower time interval) when controller 201 determines that the port positioning component 200 is more than a predetermined threshold (e.g., one inch away from the skin), and may engage at a higher frequency (e.g., between 750 Hz and 1000 Hz for a capacitive sensor) when controller 201 determines that the port positioning component is at or below a predetermined threshold range.

[0257] In some examples, the threshold range may correspond to (and take into account) the height of the port protrusion relative to the rest of the skin—for example, 0.5 to 1.0 inches away from the skin, including the end value. In practice, in some embodiments, the threshold range may correspond to the height of the protrusion of the access port to be sensed, at least to the extent that the threshold range may have the same order of magnitude as the expected height of the protrusion. In some examples, when the controller 201 determines that the distance to the skin decreases (e.g., from 1.0 inch to 0.5 inch), a higher frequency (e.g., the sampling rate of the port sensor 204) may increase from, for example, 750 Hz to 1000 Hz. In some examples, when the controller 201 determines that the port positioning component 200 is located between immediate contact with the skin and a predetermined distance (e.g., 0.0 to 0.5 inches away) (including the end value), the sensor (e.g., the port sensor) may engage at a fixed higher frequency (e.g., at the upper end of a variable range, such as 1000 Hz). This arrangement can be used to improve the detection sensitivity and power management of the device. In the example embodiment, a high-resolution analog-to-digital converter (ADC) (in conjunction with or independent of varying, spaced intervals) may be used to detect signal changes from one or more of sensors 204, 205, port sensor array 207, or skin sensor array 208. Using a lower sampling frequency for the ADC at greater distances may also result in power savings.

[0258] Regarding the sampling frequency of sensors 204, 205, port sensor array 207, or skin sensor array 208, (e.g., based on capacitive sensing), the detection of real signals may be several orders of magnitude slower than that of spurious signals (e.g., as might occur in the case of capacitive sensors), and accordingly, spurious signals can be identified and ignored by controller 201.

[0259] Therefore, as described above, in some embodiments, the controller 201 may be configured to engage one or more sensors 204, 205 or one or more sensor arrays 207, 208 at one or more different intervals during operation of one or more aspects of the device to conserve power. One aspect of operating the device may include, for example, the presence, absence, or proximity of a user's hand on the port positioning component 200, the proximity of the port positioning component 200 to the skin 123, the orientation of the implant port 130 relative to the skin surface, the orientation of the port septum 126 relative to the skin 123, and the bottom port surface 130b (see...). Figure 1B The orientation of the port positioning component 200 relative to the skin 123, the rate of translation or rotation of the port positioning component 200 relative to the skin 123 or the access port 130, or other factors. For example, this configuration can reflect a "low-power" mode with lower fidelity and a "high-power" mode with higher fidelity.

[0260] In an example embodiment, controller 201 may be configured to shorten or lengthen engagement intervals that are regularly spaced as described above, based on one or more conditions detected by controller 201, sensors 204, 204, or arrays 207, 208. For example, if data from skin sensor 205 or skin sensor array 208 indicates to controller 201 that the device is away from the skin, controller 201 may engage port sensor 204 or port sensor array 207 at a first, longer interval (e.g., energizing, sampling, polling, or interrogating). Once sensor 205 or skin sensor array 208 detects skin (e.g., within a threshold proximity), controller 201 may engage port sensor 204 or port sensor array 207 at a second interval shorter than the first interval to detect and thus accurately locate the implantable access port 130.

[0261] In an example embodiment, one or more of the sensors 204 or 205, the port sensor array 207, or the skin sensor array 208 may individually or in combination provide data to the controller 201 to locate one aspect of the access port 130 beneath the skin 123 of the implanted patient 121.

[0262] In some embodiments, data provided to controller 201 by one or more of sensor 204 or 205, port sensor array 207, or skin sensor array 208 may include one or more of the location, orientation, or orientation of the port beneath the skin 123 of patient 121. For example, data may be provided by configuring sensor 204 or 205, port sensor array 207, or skin sensor array 208 to generate detection signals for components entering the skin, soft tissue, or implanted vein ports, and then providing the detection signals to controller 201 for evaluation.

[0263] In an example embodiment, the data provided to the controller 201 by one or more of the sensors 204 or 205, the port sensor array 207, or the skin sensor array 208 may also include information for inferring an aspect of the material that forms part of the port. For example, the data may include information corresponding to the density of different materials used to construct one or more of the ports 130, the outer port housing 127, or the port diaphragm 126.

[0264] In some embodiments, the data provided to the controller 201 by one or more of the sensors 204 or 205, the port sensor array 207, or the skin sensor array 208 may also include the presence or absence of the patient 121's skin 123, or the proximity of the port positioning component 200 to the patient 121's skin 123.

[0265] In an example embodiment, data provided to the controller 201 by one or more of sensors 204 or 205, port sensor array 207, or skin sensor array 208 may be used by the controller 201 to provide feedback to the user of the positioning component 200 via one or more input / output devices 206.

[0266] In an example embodiment, one or more of the sensors 204 or 205, the port sensor array 207, the skin sensor array 208, or the controller 201 may be configured to detect or distinguish one or more materials constituting different aspects of the implant port 130. In some embodiments, the different aspects may include areas of the implant port 130 that are accessible or inaccessible using a needle. For example, the port sensor array 207 may be configured to identify one or more elements of the port 130, such as the port housing 127 or an elastomer, that can pierce the port diaphragm 126.

[0267] In some embodiments, one or more of the sensors 204 or 205, the port sensor array 207, the skin sensor array 208, or the controller 201 may be configured to identify one or more materials constituting the outer port housing. For example, the port sensor array 207 and the controller 201 may be configured to detect certain types of implanted ports 130 based on one or more shared characteristics, such as characteristics in the case of a metal, plastic, ferrous metal, non-ferrous metal, or radiopaque outer port housing 127.

[0268] In some embodiments, one or more of the sensors 204 or 205, the port sensor array 207 or the skin sensor array 208, and the controller 201 may be configured to identify one or more materials constituting the port diaphragm 126. In some embodiments, the port sensor array 207 and the controller 201 may be configured to identify one or more regions of the port diaphragm 126 that are puncturable by an elastomer, each of these regions corresponding to a puncturable diaphragm of a discrete lumen of a conduit 128 connected to the port 130.

[0269] In some embodiments, one or more of the sensors 204 or 205, the port sensor array 207 or the skin sensor array 208, and the controller 201 may be configured to distinguish between one or more materials constituting the outer port housing 127 and one or more materials constituting the port diaphragm 126. For example, the port sensor array 207 and the controller 201 may be configured to distinguish between a portion of the port housing 127 molded from a more dense, rigid material (e.g., a polymer or metal) and a portion of the diaphragm 126 molded from a less dense, elastomeric material (e.g., silicone).

[0270] In some embodiments, the port sensor array 207 and controller 201 may be configured to identify one or more aspects of the geometry, profile, or material of the punctureable elastomeric port diaphragm 126 or the outer port housing 127. In some embodiments, the port sensor array 207 and controller 201 may be configured to identify the design, model, or manufacturer of the implanted port 130 based on sensor data associated with the geometry, profile, or material of the port 130.

[0271] In some embodiments, one or more of the sensors 204 or 205, the port sensor array 207, or the skin sensor array 208 may be arranged in a shape corresponding to one aspect of the access port 130, such as the shape of the elastomeric port diaphragm 126 and / or the surrounding port housing 127. This arrangement may be used, for example, when the positioning assembly is designed to position an access port 130 of a certain type or manufacture having a specific and / or unique shape.

[0272] Detect port orientation & inversion In an example embodiment, the controller 201 may be configured to detect the orientation of the access port 130 implanted under the skin 123 of the patient 121 via one or more of sensors 204 or 205, port sensor array 207, or skin sensor array 208. Advantageously, this orientation detection can be used to distinguish between appropriate and inappropriate port orientations during device positioning of the access port 130, even if the user lacks clinical training or skills.

[0273] In an example embodiment, controller 201 may be configured to detect properly oriented access port 130 via one or more of sensors 204 or 205, port sensor array 207, or skin sensor array 208—for example, access port 130 in a normal, intended orientation, whereby access port 130 remains in the orientation required when the port is implanted under the skin 123 of patient 121, with port septum 126 and port top 130t oriented outward toward skin 123, and bottom port surface 130b oriented inward toward the internal body cavity and away from the skin surface 123. Properly oriented access port 130 can be located, accessed, and used to deliver one or more medications to the patient. Properly positioned access port can be a prerequisite for port access and medication delivery. Similarly, if the bottom of port 130 is oriented upward toward skin 123 (an unaccessible, undesirable position) and the port top 130t is oriented downward away from skin 123, an inverted access port 130 can be detected (and not used).

[0274] In some embodiments, port sensor 204 may include port sensor array 207, which is structured to detect one aspect of access port 130, including, for example, a denser material of the port housing and a less dense material of the elastomeric diaphragm. For example, in some embodiments, port sensor array 207 may include a matrix or other arrangement of sensors. For example, port sensor array 207 may include a plurality of concentrically arranged sensors, which may be or include ultrasonic (UT) sensors. In some embodiments, controller 201 may be configured to determine the location of access port 130 based on different material densities that may correspond to at least two different elements of access port 130, such as the port housing and the elastomeric diaphragm. For example, when port sensor 204, including port sensor array 207, is located directly above a subcutaneous access port under the skin, the outer ring of the concentrically arranged sensors may sense the denser material of the port housing (which may include, for example, titanium or plastic), and the inner ring of the concentrically arranged sensors may sense the less dense material of the elastomeric diaphragm. In some embodiments, the controller 201 may interpret sensed data from port sensor 204, which includes port sensor array 207, as a density map. The controller 201 may determine, based on the density map, that port sensor 204 is located directly above the subcutaneous access port. For example, the density map may include a dense circle or other outline at the center of the subcutaneous access port, corresponding to the location of port sensor 204 directly below port sensor array 207.

[0275] In some embodiments, when the port sensor 204, including the port sensor array 207, partially overlaps with the subcutaneous access port, the density map sensed from the port sensor array 207, which includes concentrically arranged sensors, may only include a portion of the dense circles or other contours of the subcutaneous access port, wherein the inner part of the circles is less dense and corresponds to the elastomeric septum, while the remainder of the density map does not indicate anything implanted under the skin. Therefore, the controller 201 can determine the direction of movement to be initiated based on the density map (including the shape of the contours) so that it is positioned directly above the subcutaneous access port.

[0276] In some embodiments, when the port sensor 204, which includes the port sensor array 207, does not overlap with the subcutaneous access port, the density map sensed from the port sensor array 207, which includes concentrically arranged sensors, may not indicate anything implanted under the skin.

[0277] In some embodiments, instead of the plurality of sensors including port sensor array 207, or in addition to the plurality of sensors including port sensor array 207, port sensor 204 may rely on the movement and use of one or more sensors that continuously sense when, for example, skin sensor 205 indicates contact with skin. For example, as port sensor 204 moves across the skin, the one or more sensors may continuously collect sensing data, which controller 201 may analyze to detect the edge of the subcutaneous access port and / or form a density map. As described above, controller 201 may use the density map to determine the position of port sensor 204 relative to the subcutaneous access port and the direction of movement required to position port sensor 204 directly above the subcutaneous access port.

[0278] In some embodiments, the controller 201 may compare sensed data (e.g., density map) from the port sensor 204 with one or more references (e.g., one or more stored subcutaneous access port profiles) to determine the position of the port sensor 204 relative to the subcutaneous access port and to identify the subcutaneous access port itself (e.g., by type, model, etc.).

[0279] In some embodiments, port sensor 204 (which may include port sensor array 207) may include an optical sensor that controller 201 may use to determine the higher reflectivity of the metal or plastic housing of the subcutaneous access port (compared to the lower reflectivity of the elastomeric diaphragm of the subcutaneous access port). Additionally, the same or different optical sensors (or different types of sensors, such as ultrasound) may be used (e.g., at an angle) to sense the reflectivity of an implant (such as an access port) not directly below port sensor 204 (e.g., off to one side), which controller 201 may use to determine the direction of movement for positioning port sensor 204 directly above the implant (such as a subcutaneous access port).

[0280] In some embodiments, port sensor 204 (which may include port sensor array 207) may include an electronic spring-loaded switch (e.g., a spring needle) and / or a mechanical palpation probe, which controller 201 may use to detect the density of an object (such as an elastomeric diaphragm under the skin or a subcutaneous access port).

[0281] In some embodiments, port sensor 204 (which may include port sensor array 207) may include different types of sensors to reduce crosstalk. For example, port sensor array 207 may include an outer ring of an ultrasonic sensor to sense the outer housing of the subcutaneous access port, while one or more inner sensors may include a "spring needle" or mechanical palpation probe to sense the elastomeric diaphragm of the subcutaneous access port.

[0282] In some embodiments, port sensor 204 (which may include port sensor array 207) may include a magnetic sensor that may use eddy current detection or Hall effect sensing to detect the housing (e.g., metal housing) of the subcutaneous access port.

[0283] In some embodiments, port sensor 204 (which may include port sensor array 207) may include a needle (e.g., a fine needle) that controller 201 may use to probe the skin (e.g., after the skin has been disinfected) to determine the presence or absence of an elastomeric septum beneath the skin. For example, after port sensor 204 has determined that it is located directly above the top of a subcutaneous access port, port sensor 204 may advance the needle sufficiently through the skin to partially puncture the elastomeric septum, thereby confirming that the elastomeric septum is located beneath and ready for medical application as described herein. Alternatively, the needle may be blunt, and controller 201 may detect the needle's rebound.

[0284] In some embodiments, the subcutaneous access port itself may include one or more near-field communication (“NFC”) tags for detection by port sensor 204, which may include a sensor for detecting NFC tags. For example, the elastomeric diaphragm of the subcutaneous access port may include four equally spaced NFC tags around its circumference, which controller 201 may detect via port sensor 204 to determine when port sensor 204 is directly above the elastomeric diaphragm.

[0285] Input & Output Devices The input / output devices 206 (which may include input devices, output devices, and devices that can both input and output) can be selected and provided based on how the positioning component 200 will be used in a particular environment or situation. One or more input / output devices 206 may also be configured to operate individually or in any desired combination, all according to instructions from the controller 201.

[0286] In an example embodiment, input / output device 206 may include one or more devices configured to sense movement, rotation, or translation of the device or housing. For example, input / output device 206 may include an inertial measurement unit (IMU), a gyroscope, an accelerometer, a combination thereof, or other suitable sensors to measure various aspects of translation and / or rotation of positioning assembly 200 during use.

[0287] In an example embodiment, input / output device 206 may include one or more ultraviolet (UV) radiation sources configured to cooperate with controller 201 to expose skin 123, 123a, 123b (see [link to relevant documentation]) before access port 130. Figure 1B One or more surfaces of the input / output device 206 are irradiated and thus disinfected. After positioning the access port 130, the input / output device 206 may emit UV radiation of one or more appropriate wavelengths of sufficient intensity and for a sufficient duration to disinfect skin surfaces adjacent to the port, as described herein. The wavelength, intensity, and duration of the UV radiation emitted by the input / output device 206 may be selected based on the skin, the expected degree of skin contamination, or other relevant factors. The wavelength, intensity, and duration of the UV radiation emitted by the input / output device 206 may also be designed based on one or more materials imposed between the input / output device 206 and the skin 123, 123a, 123b, such materials that may reduce the intensity or effectiveness of the UV radiation, such as adhesive layers, barrier layers, buffer layers, sterilizing agents on the skin, or other materials.

[0288] In an example embodiment, the input / output device 206 may include a camera, and the input / output device 206 may include an illuminator, and both the camera and the illuminator may be configured to communicate with and be operated by the controller 201 to illuminate and subsequently identify one or more aspects of the skin surface 123, the skin surface 123a surrounding the implantation port 130, or the skin surface 123b at the needle insertion site.

[0289] In an example embodiment, the camera may be configured to identify one or more harmful aspects of the needle entry point in the skin 123, the skin 123a surrounding the implantation port 130, or the skin 123b, which would render port access clinically contraindicated or unwise. Harmful aspects may include, for example, redness, erythema, edema, ipsilateral chest swelling, varicose veins, irritation, exudation, leakage, drainage, bleeding, oozing, skin damage, skin necrosis, cracking, induration, lacerations, purulent exudate or other skin conditions indicating corrosion or infection in the skin 123, the skin 123a surrounding the implantation port 130, or the skin 123b at the needle insertion site; port or catheter migration, dislocation or improper placement; port or catheter blockage or loss of patency; drug leakage or extravasation; or systemic infection.

[0290] In an example embodiment, the camera may be configured to identify one or more aspects of preparation of skin 123, skin 123a surrounding the implantation port 130, or skin 123b. One aspect of skin preparation may include, for example, the presence (or absence) of an antibacterial, antifungal, or antiviral agent on the skin surface, such as povidone-iodine, alcohol, chlorhexidine gluconate, polyhexamethylene biguanide, dyes contained in a skin sterilizing agent, or adhesive elements.

[0291] The illuminator may include light-emitting diodes (LEDs) that emit visible or invisible light, multi-color red-green-blue (RGB) LEDs, addressable or color-changing LEDs, segmented LEDs, LED matrices or panels, LED and fiber optic assemblies, liquid crystal displays, organic electroluminescent displays (OLEDs), electrophoretic displays, electroluminescent (EL) panels, EL lines, EL strips or EL fibers, or other suitable devices that provide the required wavelength and illumination intensity to work with the selected camera.

[0292] Feedback Status & Indicators One or more input / output devices 206 may be configured to provide feedback to a user of the device. In some embodiments, the feedback may include a visible indicator generated by one or more input / output devices 206 in response to instructions from a controller. The visible indicator may include a light source that produces visible light of one or more colors, such as a light-emitting diode (LED) that produces visible or invisible light, a multi-color red-green-blue (RGB) LED, an addressable or color-changing LED, a segmented LED, an LED matrix or panel, an LED and fiber optic assembly, a liquid crystal display, an organic electroluminescent display (OLED), an electrophoretic display, an electroluminescent (EL) panel, an EL line, an EL strip or EL fiber, or other suitable means that will be visible to the intended user of the positioning component 200.

[0293] In some embodiments, feedback may include a visible indicator generated by one or more input / output devices 206 in response to instructions from controller 201. For example, the visible indicator may protrude partially or completely from housing 210, or may be visibly disposed in a thinned cross-section, transparent portion, or translucent diffuser disposed within a portion of housing 210. The visible indicator may be selectively illuminated, brightened, darkened, recolored, blinked, or pulsed. Consistent or intermittent colored light signals (e.g., red, amber, green) or intermittent colored light signals or blinking patterns (e.g., red blinking, red-yellow pulses, or fast or slow blinking) may be used instead of different colors.

[0294] In some embodiments, feedback may include an audible indicator generated by one or more input / output devices 206 in response to instructions from controller 201. The audible indicator may include an audible tone, or include one or more audible tones of substantially different frequencies, pitches, or repetition rates. The frequency, amplitude, and / or waveform of the audible indicator's vibrations may vary to provide the user with indications of different states or types of information based on data received by controller 201. The audible indicator may include an audible tone of human speech, including easily understandable feedback phrases as further described herein.

[0295] In some embodiments, feedback may include a haptic indicator generated by one or more input / output devices 206 in response to instructions from controller 201. The haptic indicator may include vibration feedback, such as when input / output device 206 includes a vibration generator or vibration motor, as in a cellular phone, or when input / output device 206 includes a haptic actuator. The frequency, amplitude, and / or waveform of the haptic indicator's vibration may vary to provide the user with indications of different states or types of information based on data received by controller 201.

[0296] In some embodiments, selected feedback elements may be provided by controller 201 in combination, these feedback elements corresponding to one or more states of the positioning component 200 or the usage steps therein. In some embodiments, feedback elements may be provided by controller 201 in combination to warn the user of one or more desired, undesirable, or unsafe situations related to the positioning component 200, skin 123, skin 123a surrounding the implantation port 130, skin 123b at the needle insertion site, the access port 130 itself, port housing 127, port diaphragm 126, or the lumen of the catheter 128 of the access port 130.

[0297] In addition to the feedback provided on the positioning component 200 or housing 210, feedback may also be provided on another input / output device 206, such as a smartwatch or smartphone. This can advantageously replicate the feedback, so that the user can manipulate the device to locate the port while viewing the feedback on the phone. The feedback provided on the positioning device and the smartwatch / phone does not need to be the same. For example, the smartwatch or smartphone may offer a more detailed format, such as using a high-resolution graphics display, while the input / output device 206 on housing 210 may be simpler. In some embodiments, the feedback provided by the input / output device 206 on housing 210 may be provided in a first orientation, while the feedback provided on the smartphone or smartwatch may be reversed, so that the orientation shown on the device corresponds to the correct movement made for locating the port. In some embodiments, the other input / output device 206 (such as a smartphone or smartwatch) may be remote from the positioning component. In some embodiments, the input / output device 206 or other means of the positioning component 200 may include a wireless interface for communicating with other input / output devices 206, the communication including providing the determined location to the other input / output device 206 (e.g., the determined location may be relative to the positioning component 200). In some embodiments, the system according to the example embodiment may include a non-transitory computer-readable storage medium storing instructions that, when executed by at least one processor of another input / output device 206, may include: receiving a determined position from the input / output device 206 included in the positioning component 200; and instructing a display of the other input / output device 206 to provide feedback to the user in a visual form.

[0298] Direction & position feedback In some embodiments, directional feedback may be provided to the user, indicating the proposed direction in which the positioning component 200 moves to locate the access port 130. Therefore, in some embodiments, the controller 201 may indicate the directional feedback based on the determined position of the access port 130 relative to the positioning component 200. In some embodiments, the directional feedback may provide the user with two-dimensional information (e.g., left, right, up, down, etc.) about the position of the positioning component 200 relative to the access port 130. For example, the directional feedback may be a vector representation corresponding to the proposed direction in which the positioning component 200 moves to position itself closer to the access port 130. In some embodiments, the directional feedback may be based on data from one or more of sensors 204 or 205, the port sensor array 207, or the skin sensor array 208.

[0299] In some embodiments, directional feedback may be provided to the user, indicating a proposed translation or rotation of the positioning component 200 generally toward the implantable access port 130, toward a more intimate location toward the port 130, beyond the outer port housing 127, or beyond the pierceable portion (or center) of the port diaphragm 126. Thus, in an example embodiment, as the distance (e.g., relative proximity) between the positioning component 200 and the port 130 decreases, the visual feedback may flash with an increased frequency and amplitude. Conversely, as the distance between the positioning component 200 and the port 130 increases, the visual feedback may flash with a decreased frequency and amplitude, or may remain continuously illuminated.

[0300] In the example embodiment, as the distance between the positioning component 200 and the port 130 decreases, the frequency and amplitude of the auditory feedback can increase. Conversely, as the distance between the positioning component and the port increases, either or both of the frequency and amplitude of the auditory feedback can decrease.

[0301] In an example embodiment, as the distance between the positioning component 200 and the port 130 decreases, the auditory feedback may include an audible tone of human speech, such as “You are getting closer to the port” or “You are approaching the port.” Conversely, as the distance between the positioning component and the port increases, the auditory feedback may include an audible tone of human speech, such as “You are still on the skin” or “You are moving away from the port.” In some embodiments, the auditory feedback may include an audible tone of human speech indicating directional guidance for positioning the positioning component 200 relative to the port 130 (e.g., “Keep moving to the left,” “Move a little to the right,” “Move down,” or “Move up and to the left”).

[0302] In the example embodiment, as the distance between the positioning component 200 and the port 130 decreases, the frequency and amplitude of the vibration feedback can increase. Conversely, as the distance between the positioning component 200 and the port 130 increases, the frequency and amplitude of the vibration feedback can decrease.

[0303] In some embodiments, directional feedback may provide the user with information about the position of the positioning component 200 relative to one or more of the patient's skin 123, the skin 123a surrounding the port, or the needle entry point in the skin 123b. In some embodiments, auditory feedback may include easily understood phrases indicating feedback about the relationship between the device and the skin or the proposed direction of movement of the locator component relative to the skin, such as “keep the device against or near the skin,” “keep the device slightly away from the skin,” or “try to keep the device flat against the skin if you can.”

[0304] In some embodiments, when the positioning component 200 is substantially centered on the diaphragm center of port 130, feedback may be provided to the user of the positioning device. This feedback may include a visible, rapidly flashing light or an audible, rapidly oscillating frequency or vibration. Alternatively, if the positioning component is positioned above the port, the auditory feedback may include easily understood phrases such as “You are directly above the port.”

[0305] Error status feedback In some embodiments, the frequency and / or amplitude of visual feedback may alternate if an unsafe or unwanted condition is detected. In some embodiments, the frequency and / or amplitude of auditory feedback may alternate if an unsafe or unwanted condition is detected. In some embodiments, the frequency and / or amplitude of vibrational feedback may alternate or increase if an unsafe or unwanted condition is detected. In some embodiments, an unsafe condition may correspond to an inverted port as described herein.

[0306] In some embodiments, the positioning component 200 may perform initial calibration before positioning the port 130 or providing feedback to the user of the device. When the user first places the positioning component 200 against or near the skin 123, the positioning component 200 may not know whether it is positioned on or near the implantation port 130. In some embodiments, if the controller 201 detects, as via sensors 204 or 205, the port sensor array 207, or the skin sensor array 208, that the positioning component 200 is positioned on or possibly on the port 130, the controller 201 may provide feedback to the user to restart, thereby placing the positioning component 200 in a different initial position.

[0307] Implant Port Detection - Methods In an example embodiment, the positioning component can be used to determine the location of the port by moving the device across the patient's skin. Figure 3A An example embodiment of a method for locating a port is illustrated. For illustrative purposes, port 130 is illustrated as a single-lumen design having a rigid port housing 127, an elastomeric puncture-resistant diaphragm 126, and a catheter 128 for delivering medication to patient 121. The implantable access port 130 may have been previously placed under the skin 123 of patient 121 by a healthcare provider. The skin region adjacent to the location of port 130 may be designated 123a and may vary depending on the physiological route of administration, the specific type of access port implanted, or the patient's anatomy.

[0308] In some embodiments, the controller 301, the port position sensor array 307, and the skin sensor array 308 may be disposed within the housing 310 and configured to detect the access port 130 by distinguishing the more dense port housing 127 from the less dense port diaphragm 126. The skin sensor array 308 may include skin sensors 308a, 308b, 308c, and 308d arranged to detect the presence or absence of skin 123. The port position sensor array 307 may include peripheral port position sensors 307a, 307b, 307c, and 307d arranged to detect the more dense metal or plastic implanted port housing 127, and a central sensor 307e arranged to detect the less dense elastomer of the port 130 that can pierce the diaphragm 126. Although four skin sensors and four port sensors are shown, the embodiments are not limited thereto, and any suitable number of sensors may be used.

[0309] In an example embodiment, the port position sensor array 307 and controller 301 within the device may be configured to calculate the relative position of the positioning component 300 to one or more features and / or regions of the implantation port 130. In an example embodiment, the relative position of the positioning component 300 to the implantation port may be determined via one or more port sensor arrays when the user 311 moves the positioning component 300 to or near the patient's skin 123 or the implantation port 130. In some cases, the patient 121 may also be the user 311, such as in the case of self-administering medication. In one or more embodiments, a change in the relative position of the positioning component 300 to the implantation port 130 may correspond to a change in feedback state, which may optionally be communicated to the user of the device.

[0310] Several example feedback states will now be explained to illustrate exemplary embodiments of this disclosure and various states during use. Although by Figure 3B The example illustrated in -D shows three states, but the embodiments are not limited to this, and this example should not be construed as limiting the embodiments of this disclosure to only three states. In fact, in the example embodiment, the three illustrated states may be included among the relevant states that can be determined for locating the implanted access port, but the embodiments are not limited to this.

[0311] Example feedback status 1: The positioning component is far from the port. In an example embodiment, the controller 301 and the port position sensor array 307 may be configured to infer that the locator assembly 300 is remote from the port 130 below the implanted skin 123.

[0312] refer to Figure 3A and 3BInitially, the housing 310 may be positioned in an initial (e.g., first) position 320 away from the port 130 having the punctureable diaphragm 126, the housing being oriented so that the port position sensor array 307 is against or near the patient's skin 123. Data provided to the controller from the skin sensors 305 and skin sensor array 308 may optionally confirm that the port position sensors 304, port position sensor array 307, locator assembly 300, or housing 310 are properly positioned (e.g., oriented) against or near the patient's skin 123. Data from the port position sensors 307a, 307b, 307c, 307d, and center sensor 307e may all correspond to proximity to the skin 123 rather than proximity to the elastomeric port diaphragm 126 or port housing 127. Therefore, the controller 301 may infer that the locator assembly is neither near nor on the port 130. The controller 301 may also set one or more feedback states to correspond to "positioning component away from port" or "pin not ready to insert", and may optionally use one or more input / output devices 206 to convey the associated feedback.

[0313] Example feedback status 2: Location component is near port In an example embodiment, the controller 301 and the port position sensor array 307 may be configured to infer that the locator assembly 300 is near or close to the port 130 below the implanted skin 123, but is not yet directly above the elastomeric diaphragm 126 of the port 130.

[0314] refer to Figure 3C User 321 can translate port positioning component 300 from an initial (e.g., first) position 320 in a direction generally parallel to skin 123 to a second position 322 closer to implant port 130, until one of the peripheral sensors 307b is positioned on implantable port housing 127. Data provided to the controller from skin sensor 305 and skin sensor array 308 can optionally confirm that port sensor 304, port position sensor array 307, locator component 300, or housing 310 is properly positioned (e.g., oriented) against or near patient skin 123.

[0315] Data from peripheral sensors 307a, 307c, 307d and center sensor 307e may all correspond to proximity to skin 123 rather than proximity to port housing 127 or elastomeric port diaphragm 126. However, data from peripheral sensor 307b may correspond to proximity to metal or plastic port housing 127. By comprehensively interpreting the data from sensors 307a, 307b, 307c, 307d, and 307e, controller 301 can thus infer that the edge of positioning assembly 300 partially overlaps with port 130, the center sensor 307e of positioning assembly is not on elastomeric port diaphragm 126, and port center 129 has not yet been positioned. Controller 301 may also set one or more feedback states corresponding to "positioning assembly near port" or "needle not ready for insertion," and may optionally use one or more input / output devices 206 to convey the associated feedback.

[0316] Example feedback status 3: The positioning component is located on the port. In an example embodiment, the controller 301 and the port position sensor array 307 may be configured to infer that the locator assembly is located directly above the elastomeric diaphragm of the same port.

[0317] refer to Figure 3D User 323 can translate port positioning assembly 300 from second position 320 in a direction generally parallel to skin 123 to third position 324, which is closer to and more specifically above implant port 130. Sensor data from peripheral sensors 307a, 307b, 307c, and 307d can all be substantially equal, consistent with the sensors being located on port housing 127 (e.g., which surrounds elastomeric port diaphragm 126) rather than on skin 123 or port diaphragm 126 (e.g., corresponding to port housing). Data from central sensor 307e can be consistent with elastomeric port diaphragm 126 (e.g., corresponding to elastomeric port diaphragm). Controller 301 can interpret sensor data from 307a, 307b, 307c, 307d, and 307e and infer that the edge of the needle assembly is directly above port 130. The controller 301 may also set one or more feedback states to correspond to inferences made based on sensors 307a, 307b, 307c, 307d, and 307e. The controller 301 may also set one or more feedback states to correspond to “needle assembly on port,” “needle ready for insertion,” “skin ready,” “site ready for injection,” “injection device ready for attachment,” or another suitable state, and may optionally use one or more input / output devices 206 to convey the associated feedback.

[0318] Although translational directions and / or velocities are described for illustrative purposes, neither should be construed as limiting the device. Those skilled in the art will recognize, based on the teachings herein, that by appropriately selecting and constructing sensors, controllers, software, and supporting circuitry, a number of different states between those described herein and those not described herein will be permitted to be detected. For example, controller 301 may sample sensor arrays 307, 308 at a suitably fast rate to allow the device to move relative to skin 123 or implantation port 130 at a considerably fast rate (e.g., translating over or toward it), or to accommodate slight orientation changes of the surface of housing 310 relative to skin 123 (e.g., non-parallel orientation). Alternatively, the device may be provided with sensors and a controller configured to allow the device to translate and / or rotate relative to the port in any spatial direction.

[0319] Detection of inverted ports In an example embodiment, controller 301 may be configured to detect the inverted access port 130 by means of one or more of port sensor array 307 or skin sensor array 308.

[0320] like Figure 3E As illustrated by the example, "inverted access port" can refer to an inappropriate, undesirable orientation in which access port 130 (which is initially implanted under the skin 123 of patient 121, with port septum 126 oriented outward toward the skin 123 and bottom port surface 130a oriented inward toward the internal body cavity and away from the skin 123 surface) is subsequently and undesirably reoriented to inappropriately orient port septum 126 inward toward the body cavity and away from the skin surface, with bottom port surface 130a of port 130 oriented outward toward the skin 123 surface. The inverted access port 130 hinders the positioning, access, and delivery of one or more medications to the patient.

[0321] In an example embodiment, controller 301, port position sensor array 307, and skin sensor array 308 may be configured to infer that the locator assembly is located directly above the inverted access port. (See reference...) Figure 3F The port positioning component 300 is shown positioned on top of the inverted access port housing 127. Sensor data from the peripheral sensors 307a, 307b, 307c, and 307d can all be substantially equal, consistent with the fact that the sensors are positioned on top of the port housing 127 rather than on the skin 123 or the port diaphragm 126. This condition may initially appear to the controller 301 as corresponding to a state where the "needle assembly is on the port," as previously discussed regarding... Figure 3D As described.

[0322] However, since the data from the central sensor 307e can correspond to that located on the bottom port surface 130a instead of on the skin 123 or port diaphragm 126 as expected, this could indicate that port 130 is inverted, as... Figure 3E As shown in the diagram. Therefore, the controller can... Figure 3D The access port 130 that is correctly oriented as described in the description (e.g., where the port diaphragm 126 is oriented outward toward the skin 123) is different from an inverted port.

[0323] Controller 301 can interpret sensor data from 307a, 307b, 307c, 307d, and 307e and infer that port 130 is inverted. The controller can also set one or more feedback states to correspond to the inferences made based on sensors 307a, 307b, 307c, 307d, and 307e. Controller 301 can also set one or more feedback states to correspond to "port inverted," "port unusable for drug administration," "port unsafe or unavailable," or another suitable state, and optionally use one or more input / output devices 206 to convey the associated feedback.

[0324] Example method for locating access ports implanted in a living organism refer to Figure 10 A method 1000 for locating an access port implanted in a living organism, according to an example embodiment, may include: sensing an aspect of the access port 1010 using a sensor of a locator assembly. This aspect may include at least two different material densities of the access port, and the at least two different material densities may correspond to at least two different elements of the access port, including a port housing or an elastomer capable of piercing at least one of a port diaphragm. The method may further include: determining the location of the access port 1020 based on the difference in the at least two different material densities of the access port; and providing feedback 1030 to a user based on the determined location of the access port.

[0325] In some embodiments, outputting feedback to a user may include providing directional feedback to the user, the directional feedback including both the direction in which the locator component moves to directly overlap with the access port and the relative proximity of the access port.

[0326] In some embodiments, outputting feedback to a user may include outputting feedback to a remote device via a wireless interface.

[0327] In some embodiments, feedback may be provided via a locator component, and the feedback may be at least one of tactile, visual, or auditory.

[0328] Example method for using an access port under the skin of an implanted living organism. refer to Figure 11A method 1100 for using an access port located beneath the skin of an implanted living organism may include: sensing the proximity of 1110 to the skin using at least one skin sensor of the device. Furthermore, the method may include: instructing at least one port sensor 1120 to sense one aspect of the access port based on the proximity to the skin. Additionally, the method may include: sensing that aspect of the access port using the at least one port sensor 1130. Moreover, the method may include: determining the location of the access port 1140 by a controller based on the aspect sensed by the at least one port sensor. And, the method may include: providing feedback 1150 to a user via an output device based on the determined location of the access port.

[0329] In some embodiments, sensing proximity to the skin may further include: sensing the aspect at a first time interval when the at least one skin sensor indicates that the device is more than a predetermined threshold away from the skin; and sensing the aspect at a second time interval when the at least one skin sensor indicates that the device is at or within the predetermined threshold away from the skin. The first time interval may be slower than the second time interval.

[0330] In some embodiments, a predetermined threshold from the skin may correspond to the height of the access port to take into account any protrusion of the access port beneath the skin.

[0331] In some embodiments, the first time interval and the second time interval may correspond to the sampling rate of the at least one port sensor, the first time interval may be at or below 500 Hz, and the second time interval may be between 750 Hz and 1000 Hz, including the endpoints. In this embodiment, the at least one port sensor may include a capacitive sensor, and the first time interval and the second time interval may be the sampling rate for the capacitive sensor. In an example embodiment where the at least one port sensor includes an ultrasonic sensor, the first time interval and the second time interval of the ultrasonic sensor may be at lower frequencies, such as between 1-5 Hz and 5-50 Hz, or between 1 Hz and 5-50 Hz, respectively.

[0332] In some embodiments, the at least one skin sensor may include a spring needle, and the method may further include controlling the power to the spring needle so that contact with the skin is sensed only when the proximity of the device to the skin is within a predetermined threshold.

[0333] Example Implementation: Standalone Positioner outer shell Figure 4A-1 , Figure 4A-2 and Figure 4A-3The diagrams illustrate an exploded perspective view, a top view, and a bottom view of the positioning component according to an example embodiment. Figure 4A-4A and Figures 4A-4B The illustration shows crossing Figure 4A-2 The cross-sectional views taken along lines 4A-4A and 4A-4B show the cross-section of the positioning component according to the example embodiment, and Figures 4A-5A and Figure 4A-5B The illustration shows crossing Figure 4A-2 The cross-sectional views taken along lines 4A-4A and 4A-4B show a cross-section of the positioning assembly according to an example embodiment. (Refer to...) Figure 4A-1 In the example embodiment, the positioning component (e.g., Figure 2 200 or Figure 3A The positioning assembly (300) can be disposed in the housing 400, and includes a port sensor 401, a skin sensor 402, a controller 403, and an input / output device 404. Figure 4A-1 In an example embodiment, the housing 400 may take a well-defined, substantially linear shape. The housing 400 need not be linearly formed, but may take any suitable form, profile, size, or shape. Other alternative forms of the housing 400 may be based on the intended user group of the device; for example, an oval or handle-shaped housing may provide the fine motor control required for precise port positioning (e.g., Figure 4B-2 As shown in the figure, user limitations (such as decreased vision or dexterity, or other relevant factors that may affect the use of the device by patients with chronic diseases) are also taken into account.

[0334] The housing 400 may optionally be provided in one or more segments that may be assembled during manufacturing. For example, the housing 400 may be formed of an upper housing 400a and a lower housing 400b; a portion of the housing may include a sub-assembly of one or more components of the device described herein.

[0335] Housing sections (e.g., upper housing 400a and lower housing 400b) or housing subassemblies can be assembled into complete units using snap-fit, tabs, pawls, locking features, mechanical fasteners, ultrasonic welding, or thermoforming. Electrical components in the various sections or subassemblies of the device can be connected by the appropriate use of spring-loaded elements or "spring pins," flexible interconnects, ribbon cables, cable harnesses, modular connectors, or other suitable electrical interconnects.

[0336] One or more of the portions of housings 400, 400a, and 400b may be injection molded and may be made of any rigid material, such as nylon, acrylonitrile butadiene styrene, high-density polyethylene, polypropylene, polystyrene, polycarbonate, and other rigid polymers or other materials with suitable rigidity. If injection molded, each section of housings 400, 400a, and 400b may include portions with consistent and / or varying wall thicknesses. Some portions of the housing may be solid, or may include a rigid housing and a hollow interior. Some areas of the housing may have thinner wall sections to allow visual indicators inside the housing to be properly visible to the user from outside the housing. Wall sections may also be selectively thinned to allow the user to hear auditory feedback (such as from a speaker or piezoelectric actuator). Wall sections may also be selectively thinned to allow proper sensor operation and may be selectively thickened to shield one or more sensors, thereby preventing interference, spurious signals, or undesirable operation. The wall section can also be selectively thinned to allow NFC pairing or inductive charging (if such input / output devices are located in the device).

[0337] Each section of the housings 400, 400a, and 400b may be selectively thinned to allow a user to see or hear one or more indicators (e.g., visual or audible indicators) provided by one or more input / output devices 404 inside the housing, or to allow NFC pairing or inductive charging (if such input / output devices are located in the device). Furthermore, each section of the housings 400, 400a, and 400b may be selectively thinned to allow proper sensor operation, and alternatively, may be selectively thickened to shield one or more sensors, thereby preventing interference, spoofing signals, or undesirable operation.

[0338] In some embodiments, housings 400, 400a, 400b may be provided with one or more shielding elements to allow the sensors 401, 402 fixed therein to operate properly and to prevent spurious or undesirable operation. Housings 400, 400a, 400b may be configured to allow secondary assembly of shielding material after the housing is manufactured, or may be provided with shielding elements integral with the housing. Shielding material for sensors 401, 402 may also be provided within the housing. For example, if the housing is molded from a polymer, one or more shielding materials may be incorporated into the polymer prior to molding; shielding may also be provided through secondary assembly or incorporation of one or more materials into the housing, including internal bosses, recesses, or thickened walls, through co-molding or overmolding of one or more materials, or other suitable methods. Any combination of shielding may be used, whether inside or outside the housings 400, 400a, 400b, whether integral with or separate from the housings 400, 400a, 400b and one or more shielded components.

[0339] In certain applications or environments, housings 400, 400a, 400b, and their openings and mating surfaces, may come into contact with fluids (e.g., water, saline solution, skin disinfectant), which could cause damage to internal circuitry, electronic components, or sensors, or undesirable operation of these components. In example embodiments, housings 400, 400a, 400b may be sealed during assembly to substantially prevent fluid ingress. In some embodiments, housing 400 may be designed to prevent fluid ingress according to specific standards (e.g., ingress protection ratings of IEC 60529) and / or ratings (e.g., IP54) during assembly.

[0340] In some embodiments, areas that may be advantageously sealed include, for example, mating surfaces of housing segments (e.g., 400as, 400bs), sensor protrusions, indicators, or one or more input / output devices. The seal may include features or additional components within the housing, such as gaskets, O-ring seals, co-molded sealing features within the housing, labyrinth seals, or other seals. The seal may include features or components disposed within the housing 400, between portions of housings 400, 400a, 400b, or on one or more outer surfaces of the housing or portions of the housing, for example, housing segments 400a, 400b being joined at these features or components.

[0341] Different sealing technologies can be used for different components of the equipment, such as penetrations in housing sections 400a, 400b, or a portion of housing 400 for sensors 401 and 402 or input / output devices 404, such as visible indicators. Sealing materials and methods can be selected to prevent the intrusion of liquids (such as water, condensate), or they can be selected for compatibility with specific fluids the equipment may encounter (e.g., chlorhexidine gluconate, chlorhexidine acetate, benzalkonium chloride, povidone-iodine, alcohol, or iodine). Sealing methods can be selected and designed based on the expected duration of use or frequency of exposure.

[0342] This gasket or sealing method may be omitted, and in some embodiments, one or more components of the device (e.g., controller 403, sensors 401 and 402, printed circuit boards, circuits, or other electronic components) may be sealed against fluid intrusion by means of a conformal coating applied to one or more components of the device before or during assembly into the device. The conformal coating may comprise, for example, epoxy, acrylic, polyurethane, silicone, or UV-curable materials, combinations thereof, or other suitable materials and processes. The conformal coating may be selectively applied to one or more components and may be omitted from one or more components, such as optical input / output devices, connection points, flexible components, sensors, or other components incompatible with one or more coating materials, material properties, applications, or curing processes. The conformal coating may also be applied to one or more components of the device to prevent unauthorized access to or tampering with the electronic circuitry and components within the device.

[0343] refer to Figure 4B-1 The housing 400 can be handheld, allowing a user 420 to move the device across the patient's skin 422 to locate the implantation port 421. In this configuration, the user 420 holding the housing 400 can typically orient the user viewing surface 423 away from the skin 422 and the skin contact surface 424 closer to the patient's skin 422 during device use to locate the access port 421 beneath the implantation skin 422. In other words, when the housing 400 is in use to locate the access port, the user viewing surface 423 is closest to the user holding the device, and the skin contact surface 424 is closest to the patient with the located access port 421. Figure 4B-1 In the modification of the example shown, Figure 4B-2 An example is illustrated having the following: a housing 425, an activation button 427 for starting or ending sensing of the port, an input / output device 404 including one or more feedback indicators, and a clear viewing window 426, which may be included to aid in visualization of the skin 422, the port 421, or the raised skin caused by the port protrusion. Figure 4B-1 and Figure 4B-2 The example embodiments illustrated herein may not include the base plate as further described herein.

[0344] refer to Figure 4B-1In some embodiments, user 420 may translate or rotate housing 400 relative to skin 422 during the process of locating access port 421. Housing 400 may be grasped by user 420 and easily moved closer to skin 422 (–Z direction) or further away from skin 422 (+Z direction). Such movement may be used to bring housing 400 closer to skin and begin locating access port 421, optionally guided by skin proximity feedback provided by controller 403 and one or more input / output devices 404, as described herein. If housing 400 is close to skin, user 420 may keep housing 400 in a relatively constant relationship along the Z-axis and translate housing 400 along either or both of the ±X-axis or ±Y-axis. Such translation may be used to more precisely locate port 421, optionally guided by directional or positional feedback provided by controller 403 and one or more input / output devices 404, as described herein. The controller 403 and sensors 401, 402 may optionally be configured to adapt to varying translational and rotational speeds.

[0345] In the example embodiment, the housing 400 can move during use in any combination of translation and rotation. Although Figure 4B-1 An example Cartesian coordinate system is shown, according to which the housing 400 can be translated or rotated relative to the skin 422 and access port 421, but any axis can be used, and the translation or rotation of the housing 400 can be performed in any direction or in any combination of translation and rotation. For example, movement can also be performed as a combination of two-dimensional or three-dimensional vectors along any or all of the X, Y, and Z axes. Movement can also be performed by simultaneously rotating X*, Y*, Z* about the X, Y, and Z axes in one or more directions, and, if desired, in conjunction with translation.

[0346] In an example embodiment, the housing 400 may be provided with one or more protrusions 406 to allow the housing 400 to be more easily manipulated or to encourage the user 420 of the device to grasp the housing 400 in a specific orientation during use. For example, the protrusions 406 may encourage or enable the user to grip the housing 400 between two fingers 420a, 420b in a pinching manner, and thus orient or manipulate the device to locate the access port 421 under the skin 422, as described herein.

[0347] The raised / recessed feature 406 may include a textured finish, a color, and may be made of the same or a different material as the housing 400. For example, if the housing 400 is molded to be generally white (or light-colored), the raised / recessed feature 406 may be molded to a contrasting color or texture, such as by co-molding, overmolding, or using in-mold decoration. The raised / recessed feature 406 may also be provided with elements useful for improving grip, such as partially overmolding these features with a thermoplastic elastomer or a textured finish. The profile of the raised / recessed feature 406 may also be designed to encourage a particular grip, such as by making an example grip more comfortable than a second alternative grip; alternatively, the profile may be shaped to suggest an appropriate grip, such as by providing recesses for one or more fingers.

[0348] User viewing surface refer to Figure 4C-1A , Figure 4C-1B , Figure 4C-2A , Figure 4C-2B , Figure 4C-2C , Figure 4C-3A and Figure 4C-3B In some embodiments, a feedback indicator, provided as an input / output device 404 within the positioning component housing 400, is visible on the user viewing surface 423 to convey information to the user 420 during one or more steps of locating the access port 421 using the device. In some embodiments, the feedback may correspond to a location substantially (e.g., centered on the port) above the port 421.

[0349] In some embodiments, the input / output device 404, including a feedback indicator, may provide information to the user 420 corresponding to either or both of the relative position or proximity of the device to the implantation port 421 or a proposed movement by the user to bring the device closer to the implantation port 421. In some embodiments, the controller 403 may generate information corresponding to the relative position, relative proximity, or suggested direction of movement in response to data from sensors 401, 402.

[0350] Various examples of feedback will now be provided; however, it should be understood that these examples are illustrative and the embodiments are not limited thereto.

[0351] refer to Figure 4C-1A and Figure 4C-1B In some embodiments, a visual feedback indicator disposed on the user viewing surface 423 may include a substantially circular or annular luminous indicator 430, 432, and a center point 431 substantially coinciding with either or both of the pierceable port diaphragm or needle insertion portion of the access port 130. The annular luminous indicator may be positioned or sized to approximate the size and shape of an aspect of the access port (such as the port housing) to improve intuitiveness for the user of the device.

[0352] The ring-shaped luminous indicators 430 and 432 may also include multiple concentric rings (e.g., 430a / 430b / 430c, or 432a / 432b / 432c) extending radially from a center point 431, where the outer diameter and / or inner diameter are successively larger, and each ring has a desired spacing. The ring-shaped luminous indicator 432 may be divided into one or more segments at regular angular intervals, such as rings 432a, 432b, and 432c. Although the luminous indicator 432 is illustrated as having four segments spaced at 90-degree intervals, two or eight intervals or any other angular subdivision may be used.

[0353] In some embodiments, the luminous indicators 430, 432 may include one or more multi-segment indicators, each segment (e.g., 430a, 430b, or 430c) being illuminated individually, in combination, or sequentially, and optionally animated with a radius that expands or contracts from the center point 431 to indicate desired relative movement along a particular direction. One or more aspects of the multi-segment indicator may be animated or flashed faster or slower, or in different patterns or sequences, for example, to convey relative distance or proximity to an access port.

[0354] refer to Figures 4C-2A to 4C-2C In some embodiments, visual feedback indicators 433, 434, 435 disposed on the user viewing surface 423 may include one or more luminous indicators, arranged radially around a center point 431 at regular angular intervals, similar to the orientation on a compass. This center point substantially coincides with either or both of the pierceable port diaphragm or needle insertion portion of the access port 130. While the visual feedback indicator 433 is illustrated as having eight segments 433a-433h spaced at 45-degree intervals, two or four intervals or any other angular subdivision may be possible. The radial distances of the luminous indicators 433, 434, 435 from the center point 431 may be equal or unequal and may be determined based on the size and shape of the housing 400 and the user viewing surface 423.

[0355] Other geometries that suggest the direction of movement can also be used to provide visual feedback indicators, such as the arrows of indicators 434, 435. Multiple arrows 434a-434h can be arranged at regular angular intervals as previously described, or multiple arrows can be combined into a single direction display 435a, 435b, 435c, 435d. A portion of the direction display (e.g., one or more arrows of display 435a) can be selectively illuminated, thereby providing the ability to animated directional feedback to the user of the device. As an alternative to the specifically shaped luminous indicators 434, 435, it may be preferable to position an LED or other illuminator below the user-viewing surface 423 and then cover the LED during manufacturing by a label or in-mold decoration applied to the user-viewing surface 423.

[0356] refer to Figure 4C-3A and Figure 4C-3B In some embodiments, the visual feedback indicator 433 may include one or more luminous indicators disposed on the user viewing surface 423 and taking on a profile that suggests the outer periphery of the housing 400. While the visual indicator 433 is shown divided into eight segments, any number of segments may be used. In some embodiments, a portion of the visual indicator 433 may be selectively illuminated (e.g., illuminating 436d individually, or illuminating 436d, 436e, and 436f in combination) corresponding to a recommended direction of movement used to locate the port.

[0357] In some embodiments, the visual feedback indicator 437 may include one or more overlapping illuminated indicators disposed on the user viewing surface 423 and taking on a profile that suggests the shape of the port housing 127 or the port diaphragm 126. While the visual indicator 437 is shown as having five illuminated indicators 437a-437e, any number of segments may be used. In some embodiments, a portion of the visual indicator 437 may be selectively illuminated (e.g., illuminating 437a individually, or illuminating 437d and 437e in combination) corresponding to a recommended direction of movement for positioning the port 130. The indicators may be animated (e.g., by sequentially and repeatedly illuminating 437d and 437e) corresponding to a recommended direction of movement for positioning the port housing 127 or the port diaphragm 126.

[0358] Feedback indicators 430, 432, 433, 434, 435, 436, and 437 may be visibly disposed on a portion of the user viewing surface 423 using any combination of methods, including making one or more indicators protrude through the surface of the housing 400 or disposing them in a thinned section (e.g., 400 or 400a) that acts as a diffuser. Alternatively, feedback indicators 430, 432, 433, 434, 435, 436a-h, and 437 may be disposed below the user viewing surface 423 as previously described and selectively exposed by a cover disposed on the user viewing surface 423, such as by pad printing, screen printing, labeling, in-mold decoration, or any other suitable technique. Additionally, although not explicitly stated in Figures 4C-1A to 4C-3B The diagram is shown in the image, but directional markings can be placed on the user's viewing surface 423 to aid in interpreting visual feedback, such as directions, text, arrows, dots, or other markings, which can also be achieved through pad printing, screen printing, labeling, in-mold decoration, or any other suitable technique.

[0359] Skin contact surface Figure 4E-1 and Figure 4E-2 The illustration shows the outer casing 400 and skin 422 passing through, according to an example embodiment, such as Figure 4A-2 The perspective view shows a cross-sectional view taken by line EE. For illustrative purposes, housing 400 is shown generally above the surface of skin 422 near access port 421, wherein skin 422 is inserted between housing 400 and port 421.

[0360] The skin contact surface 424 of the outer casing 400 can be Figure 4D-1 and Figure 4D-2 The orientation shown is closest to the skin 422, which corresponds to the step of using the device to locate the implantable access port. In an example embodiment, the skin contact surface 424 may have a port sensor 401 and an optional skin sensor 402, all sensors being configured to allow detection of one or more aspects of the access port 421 and / or the skin 422. Sensors 401, 402 may be provided individually or as an array of port sensors, and these sensors and the skin sensor may be positioned to avoid interference, as previously described. One or more of sensors 401, 402 may also be located elsewhere (e.g., outside the housing 400, protruding from the housing, or separated from the housing), or may be located on other parts of the device described herein (such as adhesive elements or mating rings (as further described below)).

[0361] refer to Figure 4E-1The access port 421 can be located substantially flat (e.g., parallel) beneath the skin 422. In other words, the skin near the implantation port can remain relatively parallel to the skin contact surface 424 of the housing 400. However, the embodiments are not limited to this. Figure 4E-2 As illustrated, when implanted in a patient, the access port 421 can lift the underlying skin layer 422 or soft tissue 422', creating a protrusion 463. This protrusion interferes with the typically flat skin surface 422 and may interfere with the positioning of the port 421 by the device or the adhesion of the device or other components to the skin. The protrusion 463 can be particularly common in elderly patients or patients with advanced disease who may suffer from decreased skin elasticity (tumor bulging), reduced subcutaneous fat (lipodystrophy), or decreased muscle tone (sarcopenia).

[0362] Therefore, in some embodiments, the skin contact surface 424 of the housing 400 may also be provided with either or both of the port protrusion 461 or the flexible material layer 460 to accommodate the skin protrusion 463 generated by the implantable access port 421, thus allowing the housing 400, and in particular the skin contact surface 424, to be configured in a substantially flat manner to abut against the skin 422 surrounding the access port 421.

[0363] In some embodiments, the port protrusion 461 may be concentric or substantially concentric with either or both of the port housing or the port diaphragm. In this way, the positioning of the port protrusion 461 allows the skin protrusion 463 to project upward from the skin contact surface 424 into the port protrusion 461 within the housing 400. This advantageously retains the skin contact surface 424 and the skin 422 in a substantially flat (e.g., parallel) manner. Furthermore, since the skin protrusion 463 is lightly confined within the port protrusion 461, this advantageously provides a degree of protection against movement of the port housing relative to the housing 400.

[0364] In some embodiments, the port protrusion 461 may have a three-dimensional shape corresponding to one or more aspects of the implantation port, and thus substantially corresponding to the shape of the skin 422 and / or soft tissue 422' surrounding the protrusion 463. As constructed in any of the embodiments described above, the port protrusion 461 may allow the protrusion 463 to be raised into a specific portion of the housing 400, thus allowing the skin contact surface 424 to lie flat against the skin 422 surrounding the protrusion 463. The port protrusion 461 may be shaped as a hollow or recessed portion with conical sides, a hemisphere, or other shapes, such as any three-dimensional shape.

[0365] In some embodiments, the flexible material layer 460 may be disposed on one or more portions of the skin contact surface 424, for example, by overmolding a soft, compliant material (such as a thermoplastic elastomer or thermoplastic polyurethane), or by applying or otherwise providing an additional soft, compliant gel or foam material. Additionally, in some embodiments, one or more materials constituting the flexible material layer 460 may be disposed on a portion of the inner surface of the port protrusion 461.

[0366] The shape of the port protrusion 461 and the thickness and profile of the flexible material layer 460 can be selected based on the shape of the access port with which the device will be used and the patient characteristics regarding the degree of the protrusion 463 to be accommodated in the skin 422 and soft tissue.

[0367] Part preparation & disinfection Once the access port 421 is positioned, the housing 400 can be disposed on the skin 422 above the port 421. In some embodiments, the port protrusion 461 or the skin contact surface 424 may be configured to prepare the skin 422 once the access port has been positioned but before the housing 400 is removed from the skin 422. Figure 4F As shown, in some embodiments, the skin contact surface 424 may be configured with an input / output device 404 including one or more ultraviolet (UV) radiation sources 470 previously described, which are configured to irradiate and thus disinfect the skin 422 on the positioned port 421. In some embodiments, the port protrusion 461 may be configured with a reflective material to maximize the radiant energy exposed to the skin 422, thereby maximizing sterilization effectiveness or reducing the time required for UV exposure. In some embodiments, the input / output device 404 may include indicators corresponding to one or more states of skin disinfection (e.g., disinfection ready, disinfection in progress, or disinfection complete).

[0368] Example Implementation: Positioner Device with Adhesive + Collar Figure 5AAn example embodiment of a locator device is shown, which is configured to: locate an implantable access port as previously described with respect to the example embodiment; then prepare the skin above the located implantable port before port access; and allow subsequent patient access using a needle or drug delivery device. In the example embodiment, the locator device 500 may include a locating assembly 502 and a device-side connector 504 (both disposed in a housing 503), and a selectively removable base plate 501 having an adhesive flange 506. In some embodiments, the locating assembly 502 and the base plate 501 may be removably connected by cooperating the device-side connector 504 and the base-side connector 505. In some embodiments, the adhesive flange 506 may include one or more of a device-side layer 507, a buffer layer 508, and a skin-side layer 509. The adhesive flange 506 may optionally be provided with an oversized supportive sparse fabric or boundary 535 for attachment to the base-side connector 505 by gluing, welding, pressing, co-molding, overmolding, insert molding or other suitable permanent attachment.

[0369] base plate refer to Figure 5B In an example embodiment, the base plate 501 may include an adhesive flange 506 permanently attached to the base-side connector 505. Furthermore, in an example embodiment, the adhesive flange 506 may include: a skin-side layer 509 having a skin-side surface 512 carrying an adhesive for attaching the base plate 501 to patient skin 510 (e.g., living skin); a device-side layer 507 having a device-side surface 511; and one or more buffer layers 508 interposed between the skin layer 509 and the device layer 507, wherein layers 507, 508, and 509 may be sealed together. In some embodiments, a port protrusion 516 may optionally be provided in the base-side connector 505 (e.g., by providing a profiled section of opening 515) to allow for accommodating a skin protrusion (e.g., 463), as previously described.

[0370] One or more portions of the base plate 501 or base-side connector 505 may be injection molded and may be made of any rigid material, such as nylon, acrylonitrile butadiene styrene, high-density polyethylene, polypropylene, polystyrene, polycarbonate, and other rigid polymers or other materials with suitable stiffness. However, embodiments are not limited thereto, and in some embodiments, die-cutting may be used, for example, to form one or more portions of the base plate 501 or base-side connector 505. All or portions of the base plate 501 or base-side connector 505 may be molded into individual components for subsequent assembly or co-molded from different polymers. If injection molded, segments of the base plate 501 may include portions with consistent and / or varying wall thicknesses.

[0371] In some embodiments as described herein, the base plate 501 may be substantially rigid. However, embodiments are not limited thereto. For example, some embodiments may include a more flexible base plate 501, which may be provided to improve conformity to irregular or varying skin profiles, improve adhesive contact with the skin (e.g., consistency), and / or prevent unintentional removal of the device (e.g., as might occur due to snagging on the edge of a more rigid base plate). As described with respect to a more rigid base plate 501 according to an example embodiment herein, a more flexible base plate 501 (which may be simply referred to herein as "flexible base plate 501") may be provided with an adhesive flange 506 (optionally including one or more of a skin-side layer 509, a buffer layer 508, and a device-side layer 507) and a base connector 505 with optional port reliefs 461, as may be described herein. The flexible base plate 501 may also be provided with optional features, such as text or graphic symbols (e.g., 531g, 531t, 530o) or support features (e.g., 530) as also described herein.

[0372] In some embodiments, the base-side connector 505 may be integrally molded into the base plate 501 (which may be, for example, a rigid or flexible base plate as described herein, and may include a device side layer 507) or otherwise molded into the adhesive flange 506. This avoids the need for joining operations (e.g., joining the base-side connector 505 to the adhesive flange 506 during manufacturing, such as by using adhesive (the base-side connector and the adhesive flange as separate components)), additional features (e.g., sparse fabric 535), or multiple components (e.g., the base-side connector 505 and the adhesive flange 506). In some embodiments, portions of the adhesive flange 506 and / or the flexible base plate 501 may be co-molded from a first, more flexible material, while the base connector 505 may be co-molded from a second, more rigid material, resulting in a single component and thus simplifying manufacturing and improving the connection integrity of the base-side connector 505 and the adhesive flange 506.

[0373] In some embodiments, as discussed herein, one or more portions of the adhesive flange 506 and / or flexible base plate 501 (e.g., including device side layer 507) may comprise a more flexible material (such as those described herein), while the base connector 505 may be shaped from a more rigid material. In example embodiments, the more rigid material may include at least one of, for example, nylon, acrylonitrile butadiene styrene, high-density polyethylene, polypropylene, polystyrene, polycarbonate, other (one or more) rigid polymers, or combinations thereof. The less rigid material may include, for example, silicone rubber, thermoplastic elastomer (TPE), or blends of silicone resin or TPE and (one or more) other polymer materials, or combinations thereof, such as to achieve a desired balance of stiffness and flexibility (e.g., modulus of elasticity). Both the more rigid and less rigid materials described herein may also be selected based on skin compatibility and hypoallergenicity.

[0374] In some embodiments, the positioning component 502 may be removably pre-attached to the flexible base plate 501 during manufacturing via a device-side connector 504 and a base-side connector 505. For example, the positioning component 502 may be removably threaded onto (e.g., threadedly engaged with) the base-side connector 505 of the flexible base plate 501. Such a device may be used to position the port and adhere the base plate as described herein. The threaded connection may surround the opening 515 of the base plate including the base connector.

[0375] Because some flexible materials typically exhibit higher torsional and slid friction (e.g., silicone), in some embodiments, the materials constituting the device-side connector 504 and the base-side connector 505 may include friction-reducing materials, such as liquid or dry lubricants (e.g., silicone, such as Dow 360 silicone or other silicones commonly used in medical applications), including lubrication additives incorporated into the raw material during the molding of either threaded connection or during the molding of either component. Such constructs may be configured to facilitate easier removal of the positioning assembly 502 from the flexible base plate 501 after use, or to facilitate easier attachment of subsequent devices to the base plate after the positioning port and the flexible base plate 501 have been attached to the skin.

[0376] In some embodiments, controller 201 may determine that a device (such as base plate 501) is incompatible with an access port based on sensed aspects of the access port. In practice, in some embodiments, base plate 501 may be configured to work only with access ports from a predetermined manufacturer. In some embodiments, the locator component may provide feedback to a user indicating incompatibility. In examples, this determination may be based on identifying the manufacturer of the access port using sensed aspects. In some embodiments, the locator component may include (e.g., inherently mechanical) a locking mechanism that, upon controller 201 determining incompatibility, may instruct the locking mechanism to lock connectors 504, 505 together to prevent detachment of the locator component 502 from base plate 501.

[0377] adhesives In an example embodiment, the skin-side surface 512 may carry one or more adhesives suitable for the skin, said adhesives being configured to temporarily secure the base plate 501 to the patient's skin 510. The adhesive (which may also be referred to herein as an adhesive layer) may comprise a viscoelastic material that exhibits tackiness and adheres well to a wide variety of substrates (e.g., skin) after only slight pressure (e.g., finger pressure), such as pressure-sensitive adhesives. While the adhesive may be transparent, its color may also be altered, for example, if doing so is advantageous for intuitive application by the user of the device or for easy visualization. While the adhesive may be applied to a major portion of the skin-side surface 512, this major portion may be selectively included or excluded from one or more portions of the skin-side surface 512, for example, to aid in removal when no longer needed.

[0378] The adhesive may also be covered by a release liner, which may be a non-stick material or a film, optionally siliconeized to further enhance the non-stick properties. In some embodiments, the release liner may be removed first to allow the user to adhere the adhesive flange 506 to the skin, and the release liner may be provided cut, slit, perforated, or in one or more selectively removable segments to allow gradual exposure of the skin adhesive during user application. In some embodiments, one or more portions of the release liner are removed before the positioning port and before the base plate 501 is adhered to the skin 422. In some embodiments, one or more portions of the release liner are removed after the positioning port and before the base plate 501 is adhered to the skin 422. In some embodiments, the release liner may be helically cut so that it can be unfolded and removed from the adhesive without applying a downward force (or by applying a small degree of downward force), such that the base plate 501 remains relatively flush with the skin when the release liner is removed for adhesion. In some embodiments, the outermost portion of the base plate 501 may be flexible and includes the adhesive to which the release liner is applied. In this embodiment, after positioning the port, the release liner can be removed from the flexible portions, which can then be bent downwards to be flush with and press against the skin, thereby adhering the base plate 501 to the skin 422. In some embodiments, the adhesive may be water-activated and may not include the release liner. In this embodiment, water can be used to activate the adhesive to adhere to the skin 422 at the positioning port. However, the embodiments are not limited to this, and in other embodiments, the adhesive may be activated by other means, such as any fluid, light, vibration, etc.

[0379] An example adhesive flange 506 formed by layers 507, 508, and 509 in a direction parallel to axis YY can be a generally flat, low profile with substantially uniform thickness. However, the thickness of the adhesive flange 506 can vary widely depending on the device configuration, the characteristics of the devices to be subsequently attached to the connector (e.g., their weight), patient characteristics, the anticipated relative movement of the different parts attached to the device, the degree of skin and / or patient movement during use, ease of attachment to and removal from the skin, the skin characteristics of a particular user group of the device, or other relevant factors.

[0380] In some embodiments, multiple materials may be bonded together to form an adhesive flange 506, which includes one or more of a skin-side surface 512, a device-side surface 511, a device layer 507, a buffer layer 508, and a skin layer 509. In some embodiments, one or more of the skin-side surface 512, the device-side surface 511, the device layer 507, the buffer layer 508, and the skin layer 509 may include a conformable polymer layer, such as foam or foam composite material.

[0381] The materials constituting the adhesive flange 506 may be selected based on factors such as biocompatibility, hypoallergenicity, high skin adhesion, ease of removal from the skin, disinfection resistance, antibacterial properties, antifungal properties, antiviral properties, or other relevant factors. One or more materials may also be liquid- and / or air-permeable or airtight, or a combination thereof. One or more portions of the adhesive flange 506 may be transparent, translucent, colored, or tinted; optionally, the color or tinting of one or more materials may indicate to the user of the device the presence or type of antibacterial, antifungal, or antiviral agent (e.g., povidone-iodine, iodine, chlorhexidine gluconate, or polyhexamethylene biguanide) in the adhesive flange 506.

[0382] As previously described, port access can be a sterile procedure, and proper skin preparation may be important in some embodiments. In example embodiments, the material on the skin-side surface 512 may include an adhesive disposed on a membrane having durable antimicrobial, antifungal, or antiviral properties. Furthermore, in example embodiments, the skin-side surface 512 may be provided with an adhesive composite material comprising a pressure-sensitive adhesive and one or more durable antimicrobial, antifungal, or antiviral agents. "Antimicrobial agent" may include one or more antimicrobial, antifungal, or antiviral agents, each having a transient or durable effect. In some embodiments, such antimicrobial agent may be provided as a controlled-release formulation.

[0383] In some embodiments, a durable antimicrobial membrane disposed on the skin-side surface 512 may be configured to be in direct contact between the device and the skin 510 above the implantation port 513. For example, the antimicrobial membrane may include an iodine-containing membrane or a chlorhexidine gluconate-containing membrane, both of which are incorporated herein by reference. Alternatively, the skin-side surface 512 may be provided with an adhesive formulated in conjunction with a durable antimicrobial material to replace a separate antimicrobial membrane layer on the skin-side surface 512, or may be provided as a foam formulated with (or coated with) an antimicrobial agent.

[0384] refer to Figure 5H-1 and Figure 5H-2 In some example embodiments (such as, but not limited to, embodiments with a flexible base plate 501), the flexible base plate 501 may be configured to prevent the skin adhesive layer 520 disposed on the skin-side surface 512 from inadvertently sticking to itself rather than to the skin during removal of the backing paper. Reference Figure 5H-1 In the example, the adhesive backing 522 may initially be positioned along the centerline of the skin-side surface 512 (e.g., Figure 5H-1The adhesive layer 520 is folded at or near the vertical line in the image. A pull tab 522t may be positioned on the bottom half of the adhesive backing 522 (e.g., closest to the skin) and configured to cause a portion of the flexible base plate 501 to deflect upwards away from the skin, thereby allowing the adhesive layer 520 to be gradually exposed to the skin while protecting the unexposed portions of the adhesive layer 520. When the pull tab 522t is pulled, the user may apply downward (e.g., Z-axis) pressure to help adhere the exposed portion of the adhesive layer 520 to the skin. Thus, the adhesive layer 520 can be applied outwards from the center (e.g., opening 515) toward the periphery / outer profile of the flange, and the flange is adhered to the skin.

[0385] In some embodiments, on the other side of the skin surface 512 (e.g., on Figure 5H-1 Symmetrical adhesive layers 520 and adhesive backing 522 may exist on the middle (right side) to allow for bonding with... Figure 5H-1 and Figure 5H-2 The adhesive layer 520 and adhesive backing 522 shown in the figure adhere to the skin in the same or similar manner as described.

[0386] In some embodiments, the adhesive flange including the adhesive layer 520 and the adhesive backing 522 may include at least one through-hole so that a spring needle can extend through it and sense contact with the skin of a living body.

[0387] In some embodiments, an adhesive backing with helical cuts may be provided on the adhesive layer 520 and includes a “tear line” connected to the center of the adhesive backing (e.g., closest to the opening). The tear line may include a pull tab located at the periphery of the adhesive backing for use by a user to pull forcefully. When the tear line is pulled forcefully, the helically cut adhesive backing is pulled forcefully from the center, thus unfolding from the inside out to expose the adhesive layer 520 to the skin and adhere to the skin, particularly when the user pushes in the z-direction. Thus, this removal can be done circumferentially around the opening 515, allowing the base plate 501 to rise from the skin, and then allowing the previously exposed portion of the adhesive to contact the skin as the circumference is traversed, while the next portion rises from the skin. Thus, the adhesive can be applied from the center (e.g., the opening 515) outward toward the periphery / outer profile of the flange.

[0388] Example method for accessing the access port implanted in a living organism refer to Figure 12A method 1200 for accessing an implantable port in a living organism may include: positioning a base plate 1210 over the location of the access port. The base plate may include: an adhesive flange; and a base connector located on the adhesive flange, the base connector including an opening and an attachment configuration for attaching and detaching with a plurality of components, the plurality of components including a locator assembly for determining the location of the access port. The method may further include: adhering the base plate 1220 over the location of the access port such that the opening of the base connector corresponds to a punctureable elastomeric diaphragm of the access port.

[0389] In some embodiments, the adhesive base plate may further include: removing an adhesive backing from the adhesive layer of the base plate. The adhesive backing may be folded to form a top half that contacts the adhesive layer and a bottom half that includes a pull tab for removing the adhesive backing from the adhesive layer.

[0390] In some embodiments, the method may further include: using a locator component to determine the location of the access port.

[0391] In some embodiments, the method may further include: removing the base plate from the locator assembly after adhering the base plate.

[0392] In some embodiments, at least one of the plurality of components may be a drug application device, and the method may further include: a base connector for attaching the drug application device to a base plate.

[0393] Base-side connector & Device-side connector In some embodiments, the device connector 504 and the base connector 505 may cooperate to removably connect one or more components provided with the device connector 504 to the base plate 501. The base connector 505 and the device connector 504 may each include some or all portions that cooperate to provide retention, attachment, or detachment of a component as described herein; they may also each include separate portions of mating fittings. In some embodiments, the cooperation between the device connector 504 and the base connector 505 may be used to removably connect one or more components provided with the device connector 504 to the base plate 501.

[0394] Although base plate 501 is Figure 5BThe base plate 501 is shown as having a single connector, but one or more base-side connectors 505 (e.g., one or more) may be provided if desired. In some embodiments, the base plate 501 may be provided with one or more base connectors 505 (e.g., one or more), each base connector corresponding to one or more components (e.g., one or more) that can be attached to, detached from, or secured by the base plate 501. In some embodiments, the base plate 501 is provided with one or more base connectors 505, wherein each of the connectors 505 may correspond to a pierceable elastomeric portion of an access port 513. In some embodiments, one or more components to be attached to the base plate 501 may be provided with a device connector 504, which corresponds to the base connector 505 for attaching the component to the base plate 501. The plurality of connectors may be provided on the outer or inner surface of the base plate 501, or any combination thereof.

[0395] Different connectors can be selected or implemented in any combination or order to realize the methods described herein. For example, the first base connector 505 may be configured with external threads, while the second base connector may include internal threads, or vice versa. The base connector 505 may be equipped with external features (e.g., such as...) Figure 5B The threaded connector shown) or internal features ( Figure 5B (Not shown in the image). Similarly, the device-side connector 504 may be equipped with internal features (e.g., such as...). Figure 5B The threaded connector shown) or external features ( Figure 5B (Not shown in the image).

[0396] In some embodiments, for example, a base connector may include external threads disposed on the outer surface of a base connector 505, while a second base connector may include internal threads disposed on the inner surface of a device-side connector 504. In an example embodiment, connectors 504 and 505 may take a complementary cylindrical form, thereby allowing the outer surface of one connector to rest on and flush with the inner surface of the other connector. For example, as Figure 5B As illustrated, the inner surface 504e of the device-side connector 504 can be placed on and flush with the outer surface 505e of the base-side connector 505. In this text (and for example in…), Figure 5B The examples of the base-side connector 505 and device-side connector 504 depicted in the illustration are intended to be illustrative, and the embodiments are not limited thereto. For example, although the base-side connector 505 is shown to have an external thread and the device-side connector 504 is shown to have a corresponding internal thread, the embodiments are not limited thereto, and the external / internal nature of such threads may be reversed.

[0397] Similarly, although in Figures 5C-1 to 5C-4The example embodiments illustrate a threaded quarter-turn lock, but connectors 504 and 505 are not limited to threaded connections. For example, connectors 504 and 505 may include any suitable removable connector that can be selected for a secure connection and protection against accidental, unintended, or premature disconnection. Connectors may include, for example, internal or external threads (or portions thereof), press-fit or interference-fit elements, tapered elements, bayonet fittings, pins and pawls, spring-loaded connectors, locking collars, snap-fit ​​connectors, hooks, barbed fittings, magnetic connectors, or other suitable connectors.

[0398] Attachment of components to base plate In some embodiments, one or more components of the positioning device may be provided with one or more device connectors 504 for attachment, detachment, or retention on a base plate 501 having a base connector 505. In some embodiments, one or more components other than the device described herein may be provided with device connectors 504 for attachment, detachment, or retention on a base plate 501 having a base connector 505. In addition to the positioning assembly 502, the component provided with the device connector 504 may also include, for example, a drug application kit or a drug delivery device.

[0399] In an example embodiment, the adhesive flange 506 having the base-side connector 505 may be configured to removably connect one or more components characterized by the device-side connector 504 (such as multiple components including a drug delivery device and a positioning assembly 502) to the base plate 501. In an example embodiment, the removable connection may include one or more of attachment, detachment, or retention of the components characterized by the device-side connector 504 to the base plate 501 adhered to the patient's skin 510.

[0400] The component equipped with the device connector 504 can be connected to the base plate 501 during manufacturing using the base connector 505 (e.g., by pre-assembly or pre-connection), and can be connected by the user of the device (e.g., during one or more steps of use of the device or its components), or a combination thereof.

[0401] In an example embodiment, the housing 503 containing the locator assembly 502 may be provided with a device connector 504 and may be removably pre-attached to the base plate 501 via a base connector 505. In this configuration, the locator assembly 502 can be used to locate the port and then the base plate 501 is temporarily placed on the patient's skin 510 above the implantation port 513 with adhesive, after which the locator assembly 502 is removed from the base plate 501.

[0402] In some embodiments, a drug delivery device (such as a needle assembly, autoinjector, wearable syringe, or other drug delivery device) may be attached to a base plate 501 via connectors 504, 505 to obtain a straightforward and accurate pathway to the positioned port 513, and in particular the puncturable elastomeric diaphragm 513s. This exemplary embodiment may be advantageous when drug delivery lasts for an extended period (e.g., minutes to hours) and both port positioning and retention of the drug delivery device are required.

[0403] In some embodiments, without the use of connectors 504, 505, a drug delivery device (such as a needle assembly, autoinjector, wearable syringe, or other drug delivery device) can be directly inserted through the opening 515 in the base plate 501, thereby obtaining a straightforward and accurate passage to the positioned port 513, and in particular the puncturable elastomeric diaphragm 513s. This example embodiment may be advantageous when the duration of drug delivery may be short (e.g., seconds to minutes), port positioning is required, and device retention is not necessary.

[0404] In some embodiments, connectors 504, 505 may be selected, constructed, or designed taking into account factors such as: the forces and torques applied during use of the device and components attached thereto (including the sequence of attachment and disassembly), the size, weight, or structure of the device to be attached to base plate 501, the duration of fixation on base plate 501 (e.g., the duration of drug delivery to port 513), movement or operation of the device attached to base plate 501, the anticipated degree of patient movement when base plate 501 is on skin 510, or other relevant factors. Multiple connectors may be selected if desired, and each connector 504, 505 may be selected independently if desired. For example, a less robust connector may be used to removably attach a lightweight positioning component 502 that is temporarily fixed when the port is positioned, while a more robust connector may be selected to attach a heavier device, such as a drug delivery device, that is fixed for several hours.

[0405] The materials used for connectors 504 and 505 can be selected based on the nature of the connectors. In some examples, such as threaded or bayonet fittings, more rigid materials can be selected; in the case of press-fit, interference fit, snap-fit, or snap-over connections, materials with balanced plastic and elastic properties can be selected. Threaded connectors may optionally be equipped with one or more supports or stops to prevent excessive rotation during attachment or disassembly, thereby reducing torque or force on the base plate 501 or the bonding flange 506. Similarly, pawls may be provided on any one or both of connectors 504 and 505 to provide tactile feedback to the user of the device or to prevent accidental disassembly of the device from the base plate 501 during attachment of the device to or removal of the device from the base plate. Furthermore, the interface between connectors 504 and 505 may be selected to prevent accidental disassembly of components attached to the base plate 501 and the base plate connector 505 using the device-side connector 504 due to vibration, movement, or other factors.

[0406] In some embodiments, while the base-side connector 505 on the flexible base plate 501 may be a threaded connector or other connector as described herein, the embodiments are not limited thereto. In fact, connectors (e.g., device connector 504 and / or base connector 505) may be designed to utilize the underlying flexible material properties of the base connector 505.

[0407] For example, refer to Figure 5E Instead of a threaded connection, the base connector 505 may be provided with a slotted barbed configuration 560 including a plurality of flexible fingers 562, which serve as "easy-to-attach" flexible connections when attaching / removing, for example, the positioning assembly 502 or other devices. In some embodiments, the slotted barbed configuration may include the plurality of fingers 562 in a circular configuration and circumferentially spaced around the opening 515, with a plurality of slots between the plurality of fingers. In some embodiments, the fingers 562 may be made of an elastic material and may be arranged as indicated by arrow 563 (see...). Figure 5F The fingers 562 deflect in the opposite radial direction. The deflection of the plurality of fingers 562 may be based on the elastic modulus of the elastic material. Each of the fingers 562 may include a barb 564 at its distal end. In some examples, the barb 564 may include a hook shape to correspond to a reference. Figure 5F-5G The protruding grooves 582 discussed interact. In some embodiments, this configuration 560 may replace the threaded connection of the connectors 504, 504 as described herein.

[0408] refer to Figure 5FThe first device 580 (such as port positioning assembly 502 or other components) may be provided with cooperating device-side connector features (e.g., circumferentially projecting recesses 582 protruding from the sidewall of the first device 580), which can be pushed onto barbed fittings provided by barbs 564 of the plurality of fingers 562, thereby securing the first device 580 in place with the base plate 501. In the example configuration, the flex is "locking," but is secured only by friction and recesses. This configuration with the port positioning assembly 502 attached allows for positioning of the access port and attachment of the base plate 501 to the skin, as described herein.

[0409] In an example embodiment, without the internal "support" provided by the first device 580 within the finger 562, the finger can freely flex inward, allowing the user to easily remove the first device 580 from the base plate 501 (e.g., once the base plate 501 adheres to the skin). For example, for ease of removal, the port positioning assembly 502 of the first device 580 may not include such a support, allowing it to be easily detached from the base plate 501 once it is positioned and adhered to the access port. Similarly, the first device 580 can also be easily attached to the base plate 501 as needed. The ease of removal and attachment of the first device 580 from / to the base connector 505 of the base plate 501 can be adjusted by the size and profile of the barb, the size and profile of the protruding groove 582, the spacing between the finger 562 and the device side connector features (including the sidewalls and the protruding groove 582), and / or the elastic modulus of the finger.

[0410] refer to Figure 5G A second device 590 (which may be a drug delivery device, such as an on-the-lamp injection (OBI) (e.g., a wearable syringe) or a needle assembly (e.g., needle assembly 700 as described herein)) may be attached to a barbed configuration 560 of the base connector 505, for example, by pushing the second device and retracting the finger 562 into a recess. For example, the second device 590 may be attached once the first device 580 has been positioned at the access port and has been detached. In some embodiments, the second device 590 may include a central stabilizing structure (e.g., a tapered support 594) that prevents substantial inward flexing of the finger 562 and thus holds the second device 590 to the base plate 501 to a greater extent once connected. For example, the support 594 may restrict movement of the finger 562 compared to an unsupported configuration.

[0411] The degree of retention can be calibrated to prevent (e.g., restrict) or resist removal. For example, the taper of the support 594, the elastic modulus of the fingers 562, the gap between the fingers 562 in the annular opening 595 of the second device 590 (which is located between the support 594 and the sidewall including the protruding groove 592), and / or the size and profile of the barb 564 may affect the degree of retention to prevent or resist removal of the second device 590 from the base plate 501.

[0412] In an example embodiment where the calibrated retention level prevents removal, this allows the used device (e.g., a second device 590 including an OBI or needle assembly) to be removed as a single unit along with the base plate 501 at the end of medication delivery. In an example embodiment where the calibrated retention level resists removal, this provides improved protection against unintentional disconnection of the second device 590 attached to the base connector, while still maintaining the ability to remove the used second device 590 from the base plate 501 and then, or at a later time, attach another device (e.g., an OBI device or a second needle equipped with a device-side connector for subsequent administration of the same and / or different medications).

[0413] Buffer layer In some embodiments, one or more buffer layers 508 may be permanently inserted between the skin-side surface 512 and the device-facing surface 511. Buffer layers 508 may be included to provide desired properties based on usage conditions, and may be composed of any number of materials suitably attached to each other. In some embodiments, buffer layers 508 may also include device-side layers if a device-side layer 507 is not provided in an embodiment of the device. The thickness, orientation, color, shape, barrier properties, antimicrobial properties, absorbent or repellent properties, or other characteristics of any material in buffer layers 508 may vary. For example, in cases where an adhesive flange is provided to a patient receiving a hazardous drug (e.g., an antitumor drug, a teratogenic drug), buffer layer 508 may include a barrier material against the hazardous drug (such as acrylic or natural rubber latex) or a barrier designed to prevent atomization of the drug administered through access port 513. In another example, the buffer layer 508 may include a soft, compliant foam (e.g., polyurethane or hydrogel foam) to cushion the skin when one or more devices (such as a rigid infusion needle assembly that may cause skin irritation or pain to the patient) are attached to the base plate 501.

[0414] The base plate 501, and particularly the adhesive flange 506, can withstand various dynamic stresses and strains, especially when the skin 510 of a patient wearing the base plate 501 moves, or when a device (e.g., a locator assembly, needle assembly, or drug delivery device) is attached to or removed from the base plate 501 via the device-side connector 504 and the base-side connector 505. The buffer layer 508 can act as a strain relief between components attached to the base plate 501 with the base connector 505 via the device-side connector 504, thereby reducing the risk of accidental dislocation of components by uniformly distributing any load, force, or stress onto the adhesive flange 506. When a device with a needle is attached to the base plate 501 and the needle is inserted into the port 513 for drug delivery, the strain relief provided by the buffer layer 508 advantageously prevents patient discomfort.

[0415] For example, by using materials with sufficient thickness and a balance of deflection, ductility, or stiffness, buffer layer 508 can be configured to allow for greater axial or torsional deflection along a first direction or dimension and less axial or torsional deflection along a second direction or dimension. One or more materials constituting buffer layer 508 can be selected based on porosity, viscosity, density, hardness, deflection, cushioning effect, or other relevant factors, and said one or more materials may include, for example, open-cell or closed-cell foams or hydrogels. Different materials constituting buffer layer 508 can also be used in one or more portions of the buffer layer with different orientations, thicknesses, profiles, or geometries, and may not need to constitute an entire layer of a single material.

[0416] In other words, the buffer layer 508 may be configured to selectively resist or permit forces or torques in one or more directions. In some embodiments, once attached to the skin 510, the adhesive flange 506 may be configured to permit relative movement or flexure between the adhesive flange 506 and the components attached thereto by the connectors 504, 505 in one or more directions. In some embodiments, once attached to the skin 510, the adhesive flange 506 may be configured to restrict or resist relative movement or flexure between the adhesive flange 506 and the components attached thereto by the connectors 504, 505 in one or more directions.

[0417] For example, a wearable syringe with device-side connector 504 can be rotated clockwise to attach to base-side connector 505 and counterclockwise to detach from base-side connector 505. Clockwise torque is permissible, but a higher resistance to counterclockwise torque is provided, which could cause unintentional removal of the device from base plate 501. In some embodiments, once attached to skin 510, adhesive flange 506 can be configured to restrict or resist relative movement or flexure in a first direction between adhesive flange 506 and components attached thereto by connectors 504, 505, and to permit relative movement or flexure in a second direction between adhesive flange 506 and components attached thereto by connectors 504, 505.

[0418] Adhesive flange support refer to Figures 5C-1 to 5C-4 In an example embodiment, the adhesive flange 506 may project outwardly in profile from the base-side connector 505 along one or more directions and / or dimensions, and is also configured to attach the base-side connector 505 to the skin 510 near the access port 513 implanted in the patient 514. The outwardly facing profile, and particularly the radially outward profile, of the adhesive flange 506 may take any external shape, such as circular, elliptical, square, rectangular, rhomboid (e.g., external profile 533), star-shaped, other shapes, or combinations thereof. The outwardly projecting protrusion may alternatively, for example, suggest the shape of a component later attached to the base plate 501 (such as the external profile of the positioning assembly 502, needle assembly, or drug delivery device), or another shape. The adhesive flange 506 may also be profiled to ensure proper skin attachment, although unevenness may be caused by the raised skin protrusion (caused by the implantation port below). In some embodiments, the adhesive flange 506 may have a curved shape such that only the central portion is in contact with the skin, while the outer edges are higher. In some embodiments, segments of the outer contour 533 may include portions with consistent and / or varying wall thicknesses (e.g., if injection molded). For example, portions of the outer contour 533 may have thinner segments further away from the opening 515 and thicker segments closer to the opening 515 (i.e., tapering from thinner to thicker toward the port opening 515). This feature improves resistance to unintentional removal of the adhesive flange 506.

[0419] The adhesive flange 506, or a portion thereof, may also be provided with one or more openings 515 disposed on the interior of one of the flange surfaces or components thereof. In some embodiments, the openings 515 in the adhesive flange 506 may be provided to visualize the implantation port site, visualize the skin above the implantation port, or accommodate a drug delivery device (which may also be referred to herein as a drug application device). In examples, the opening 515 may include a circular profile having a center point and a desired diameter. For example, the opening 515 may have a relatively large diameter, thereby allowing unobstructed access to the skin above the center of the implantation port. In another example, the opening 515 may have a relatively small diameter, thereby allowing unobstructed insertion of an injection needle through the flange. In some embodiments, the opening 515 of the adhesive flange 506 may be aligned with the opening of the base connector 505. In some embodiments including one or more port sensors 204, the one or more port sensors 204 may sense one aspect of the access port through the openings of the adhesive flange 506 and the base connector 505. In some embodiments including one or more skin sensors 205, the one or more skin sensors 205 may sense proximity and / or contact with skin through openings in the adhesive flange 506 and the base connector 505. In an example, at least one of the one or more skin sensors 205 may include a spring pin. However, embodiments are not limited thereto, and additionally and / or alternatively, in some embodiments, one or more skin sensors 205 (which may include spring pins) may extend through and / or sense through corresponding one or more additional through-holes (e.g., openings) in the base plate 501 to sense contact or proximity with skin. In some embodiments, the base plate 501 including the adhesive flange 506 may include a plurality of openings, each corresponding to a plurality of skin sensors 205 so that the skin sensors 205 pass through them to sense skin.

[0420] In some embodiments, one or more openings 515 may be provided to allow proper operation of one or more sensors that would otherwise be obstructed by one or more aspects of the adhesive flange 506 or its components. The openings for allowing proper sensor operation may include, for example, selective removal, profile, shaping, thinning, stamping, compression, or other forming, shaping, or removal processes of one or more materials in the adhesive flange 506.

[0421] Openings may be provided during the manufacture of the adhesive flange, during operation of the device or other components, or a combination thereof. During manufacture, openings may be created by die-cutting, punching, perforation, laser cutting, waterjet cutting, molding, or other suitable processes. In some embodiments, opening 515 may be formed when a drug delivery device coupled to the base plate 501 advances a needle from the device side surface 511 through the adhesive flange 506 to the skin side surface 512, thereby piercing the flange 506 and subsequently piercing the skin 510 and / or port 513.

[0422] In some embodiments, the adhesive flange 506 may be provided with a support feature 530 on either or both of the skin-side surface 512 and the device-side surface 511. The support feature may be included to prevent the skin-side surface 512 from unintentionally or undesirably adhering to the patient's skin or another portion of the adhesive on the skin-side surface 512 when the adhesive is exposed (e.g., when the release liner is removed). The support feature 530 may also be used to reinforce the adhesive flange 506 and improve the user's ability to adhere the adhesive to the skin 510.

[0423] Like the adhesive flange, the support feature 530 can be a low-profile planar element, such as a paper, polymer, or metal element, or a combination thereof. In some embodiments, the support feature 530 may be profiled away from the generally planar surface of the adhesive flange 506, positioned or applied to cause the adhesive flange to bend upward at its periphery (e.g., the outer edge of the flange 506 relative to the opening 515) and away from the skin-side surface 512 and skin 510 before the padding is applied or easily removed. For example, the polymer or metal support structure 530 may be molded or shaped to have a profile, or a paper element may be applied during manufacturing to a surface having an adhesive flange that deforms upward from the skin-side surface 512, thus temporarily deforming the periphery of the adhesive flange 506 away from the skin-side surface 512.

[0424] The support feature 530 can be removably attached to the skin-side surface 512 or the device surface 511. The support feature 530 can prevent the adhesive flange 506 from wrinkling (which could impair the sterile barrier between the patient's skin and the external environment, such as air or contact with contaminants) or can be configured to allow the user to progressively apply the adhesive on the flange 506 to the skin. For example, the adhesive flange 506 can be adhered to the skin 510 first closest to the opening 515 and then outward toward the periphery of the adhesive flange 506.

[0425] Device side surface & markings In some embodiments, the device side surface 511 of the base plate 501 may be provided with markings or symbols to provide the user with instructions on the proper use of various aspects or components of the device, one or more steps of using the device, or information about the device or its components.

[0426] In some embodiments, the markings may include the outline of the positioning component 502 or its housing 503 to properly orient the device during attachment or removal using the connectors 504, 505. The markings may also include one or more of the following: icons, graphics, text, usage step numbers, batch number information, expiration data information, pharmaceutical information, guidance text, warnings, precautions, information about compatible and / or incompatible products, or other information relevant to the user of the device.

[0427] refer to Figure 5C-1 The device side surface 511 may be provided with one or more of the following: graphic symbol 531g, text symbol 531t, symbol number 531i, or outline 503o. Graphic symbol 531g may indicate the movements required for proper use of the device, such as rotation. Text symbol 531t may indicate the numerical sequence of usage steps, instructions for using the device, or other textual information (e.g., part number, batch number, or expiration date). Symbol number 531i may be presented to indicate the operation of the device, as in the example icon shown for removing an adhesive pad from the skin side surface 512. Other icons, graphics, text elements, or outlines may be presented based on the context in which the device is used.

[0428] In some embodiments, markings (such as outline 503o) may visually suggest the outline of housing 503 (e.g., take the shape of the outline; be slightly smaller or slightly larger than the outline) and indicate the correct (or incorrect) orientation of housing relative to adhesive flange 506 or base plate 501, thereby enabling the user to correctly orient the components of the device during attachment or disassembly using connectors 504, 505.

[0429] refer to Figure 5C-2 The device side surface 511 may be provided with one or more of graphic symbols 535g, a first contour line 537, and a second contour line 538. Graphic symbols 535g and 536g may indicate the movements required for proper use of the device, such as rotation. The first contour line 537 and the second contour line 538 may visually suggest the contour line of the housing (e.g., 503) (e.g., take the shape of the contour line; be slightly smaller or slightly larger than the contour line) and indicate one or more orientations of the housing in various steps of attaching to the adhesive flange 506 or the base plate 501, thereby enabling the user to correctly orient the components of the device during attachment or removal of the device using the connectors 504 and 505.

[0430] For example, the first outline 537 may correspond to the position of the housing when it is pushed onto the base plate 501 in a direction toward the skin. The housing can then be rotated clockwise, as indicated by graphic symbols 535g, 536g and letter symbols 535t, 536t. Continuing this example, the second outline 538 may correspond to the position once the housing is attached to the base plate 501, thereby enabling the user to correctly orient the components of the device during attachment or removal using connectors 504, 505.

[0431] refer to Figure 5C-3 The skin-side surface 512 may be provided with one or more markings, as previously described with respect to the device-side surface 511. Although textual markings 539t indicating the proper orientation of the adhesive flange 506 relative to the skin are provided by way of example, any or all of graphic, icon, or textual markings may be provided on the skin-side surface 512 or the device-side surface 511.

[0432] refer to Figure 5C-4 In some embodiments, the device side surface 511 may be provided with one or more markings arranged to selectively hide or reveal to the user of the device based on one or more components attached to the base plate 501. Selective hiding or revealing can have the advantage of conveying information to the user of the device as previously described, while avoiding the possibility of the user being confused by multiple sets of information visible simultaneously. For illustrative purposes, graphic markings 540g and 541g and text markings 540t and 541t are provided together with a first outline 542 and a second outline 543.

[0433] The first contour line 542 may correspond to the position of the housing when it is pushed onto the base plate 501 in a direction toward the skin. Graphical markings 540g and text markings 540t may be visible, indicating the correct orientation for assembly onto the base plate 501. However, placing the housing over the contour line 542 may conceal the graphic markings 541g and text markings 541t indicating the removal step. The housing may then be rotated clockwise, as indicated by the graphic markings 540g and text markings 540t. Continuing this example, the second contour line 543 may correspond to the position once the housing is attached to the base plate 501, allowing the user to correctly orient the components of the device during attachment or removal using connectors 504, 505. Therefore, clockwise rotation of the housing may conceal the graphic markings 540g and text markings 540t and expose the graphic markings 541g and text markings 541t indicating the removal step.

[0434] Other variations are possible. In some embodiments, markings may be arranged on the device side surface 511 to be visible to the user of the device when the first component is attached to the base plate 501 and then hidden when the second component is subsequently attached to the base plate 501 (both attached via connectors 504, 505). The reverse is also possible. Markings may be arranged on the device side surface 511 to be hidden from the user of the device when the first component is attached to the base plate 501 and then revealed when the second component is subsequently attached to the base plate 501 (both attached via connectors 504, 505).

[0435] Selectively concealed markings can be particularly advantageous when components are pre-assembled to the base plate as described herein. In some embodiments, markings (e.g., 531g, i, t, 540g, 540t, 541g, 541t) provided on the device side surface 511 may initially be exposed by a first part pre-attached to the base plate 501, and subsequently exposed to the user of the device when the first component is removed from the base plate 501 and the base-side connector 505.

[0436] In some embodiments, one or more markings (e.g., 531g, i, t, 540g, 540t, 541g, 541t) disposed on the device side surface 511 may initially be hidden by a positioning assembly 502 pre-attached to the base plate 501, and subsequently exposed to the user of the device when the positioning assembly 502 is removed from the base plate 501 and the base-side connector 505. For example, the first component may be the positioning assembly 502 pre-attached to the base plate 501 via connectors 504, 505, the second component may be a drug delivery device, and the one or more hidden markings (e.g., 531g, i, t, 540g, 540t, 541g, 541t) may include attachment instructions for the drug delivery device.

[0437] Port locator assembly removed and port accessed via the fixed base plate and (one or more) connectors Figure 5D-1 A positioning assembly 502 is shown removably attached to a base plate 501. Both the base plate and the positioning assembly are temporarily placed on the patient's skin 510 above the implantation port 513 with adhesive, wherein the opening 515 is positioned on the punctureable portion of the elastomeric diaphragm 513s, as previously described.

[0438] Now for reference Figure 5D-2 Then, by disconnecting the device-side connector 504 from the base-side connector 505, the positioning assembly 502 is removed from the fixed base plate 501. Figures 5D-1 to 5D-3In the illustrated example, connectors 504 and 505 may form a threaded connection, and disconnection may be achieved by rotating the positioning assembly 502 counterclockwise 551 to unscrew the positioning assembly 502 from the base plate 501.

[0439] In some embodiments, after the positioning component 502 is removed, the opening 515 in the base plate 501 may remain positioned over the punctureable portion of the elastomeric diaphragm 513s. (See reference...) Figure 5D-3 The unlocked positioning component 502 can be removed by grasping it in the hand and pulling it in a direction 552 away from the fixed base plate 501 (e.g., in reference). Figure 5D-2 (After the disconnection described in the example). In some embodiments, the base plate 501 fixed to the skin 510 can substantially resist torque (e.g., 551) or force (e.g., 552) caused by the removal of the positioning component 502, thereby keeping the opening 515 substantially positioned over the punctureable portion of the elastomeric diaphragm 513s.

[0440] Removing the positioning component 502 exposes the interior of the base connector 505 and the opening 515, which can be configured to subsequently allow access to an aspect of the implantation port 513 (e.g., a puncturable portion of an elastomeric diaphragm 513) positioned according to the devices and methods described herein by way of example.

[0441] This configuration allows for the visibility of the skin 510 above the port 513 (e.g., for skin preparation or site marking) to allow the needle of the drug delivery device to be inserted into a portion of the puncturable elastomeric diaphragm 513s of the implantable access port 513. For example, the drug delivery device can be any device with an injection needle, such as a hollow-hole percutaneous needle (e.g., a Huber needle) with a curved cannula and a deflected pointed end, or a needle assembly, an autoinjector, a wearable injector, all as described herein. Additionally, drug delivery devices other than those described herein can be used, and other procedures (e.g., site marking, site disinfection, blood draw, blood donation, blood transfusion, hemodynamic monitoring, contrast agent administration for imaging studies, dialysis) can be performed through an opening 515 on one side of the implantable port 513 or the puncturable portion of the elastomeric diaphragm 513s.

[0442] In some embodiments, the access port 513 or the pierceable port diaphragm 513s may be accessed via the opening 515 when connected to the base connector 505. In some embodiments, the access port 513 or the pierceable port diaphragm 513s may be accessed via the opening 515 without being connected to the base connector 505.

[0443] exist Figures 5D-1 to 5D-3In an example embodiment, the base connector 505 is shown to take an annular shape, which is disposed or disposed on top of the implantation port 513, and particularly the punctureable portion of the elastomeric diaphragm 513s, located according to the embodiments described herein. In some embodiments, the opening 515 may include an inner annular center disposed above a portion of the punctureable elastomeric diaphragm of the implantation port. For example, the inner diameter of the annular face may be approximately the same as the diameter of the punctureable elastomeric port diaphragm. However, the shape of the opening 515 may not need to be annular or circular; for example, it may be square, rectangular, elliptical, or other geometry, such as the geometry taken by the outer shell of the port or by the punctureable elastomeric port diaphragm of the port. Further, multiple openings may be present, each with a different shape and configuration. Further, each of the cooperating base connector 505 and device connector 504 may not need to have the same opening shape; different openings may be used for each.

[0444] Skin preparation In some embodiments, the internal opening of the base plate disposed on the skin, as described herein, may be configured to allow insertion of a component having a shape that cooperates with the shape of the internal opening, for preparing the skin, disinfecting the skin, or marking the skin.

[0445] like Figure 6A-1 and Figure 6A-2 As shown, in some embodiments, a disinfecting swab 601 may be configured to be placed through an opening 515 in a base plate 501 disposed on skin 510 for the purpose of preparing (e.g., disinfecting) the skin near the implantation port 510p. The swab 601 may be rigid for easier handling by a user 605 (such as a healthcare provider or patient) and may have a compliant end 602 (e.g., made of foam material) that is compressible when rotated relative to skin 603 or pressed against skin. A sterilizing agent may be disposed on the swab end 603, including, for example, alcohol, iodine, povidone-iodine, oxytinidine dihydrochloride, chlorhexidine gluconate, or other suitable sterilizing agents. In some embodiments, the sterilizing agent on the swab 601 may have durable antibacterial activity.

[0446] like Figure 6B-1 and Figure 6B-2 As shown, in some embodiments, the marking device 610 may be configured to be placed through an opening 515 in a base plate 501 disposed on the skin 510 for marking a portion of skin near the implantation port 510p or a punctureable elastomeric septum. The marking device 610 may also have an end 611 with ink or dye (such as gentian violet, methylene blue, or other skin-compatible marking substances). Figure 6CAs seen in the image, this marking device can make, for example, dots, crosshairs, or circular marks 615 on the skin 510. The marking device 610 may optionally be sterile to maintain the sterility of the prepared site (e.g., after using a disinfectant swab 601).

[0447] In an example embodiment, the disinfectant swab 601 or marking device 610 may not be secured by the base connector 505, but instead may be aligned and guided into the internal opening 515 and then axially advanced toward the skin 510, particularly toward the skin 510 near the port. However, in some embodiments, the marking device 610 or disinfectant swab 601 may also be provided with a device connector (not shown) if a removable connection to the base plate 501 is required.

[0448] Example Implementation: Drug Application Using the Retained Base Plate Refer again Figures 5D-1 to 5D-3 And for the purpose of describing the following example embodiment, it is assumed that the access port has been positioned as previously described, the positioning assembly 502 has been removed from the base plate 501, the base plate 501 is provided with the base connector 505, and the opening 515 is disposed on the skin 510 above the punctureable portion of the elastomeric diaphragm 513s, all as previously described. Additionally, the skin 510 may have been positioned as described in reference... Figure 6B-1 and Figure 6B-2 As described, they are marked and / or disinfected. One or more drug delivery devices (which may be referred to herein as one or more components, with locator assembly 502 being another component) equipped with device-side connector 504 can then be attached to the anchored base plate 501 and deliver the drug to the patient through the skin 510 and septa 513s. For example, a user can then attach one or more different devices having device-side connector 504 to base plate connector 505 and thus to base plate 501, thereby obtaining access to the skin 510, access port 513, or port septa 513s, for example, using an injection needle.

[0449] In some embodiments, a device-side connector 504 disposed in a drug delivery device may be configured to cooperate with a base-side connector 505 in a fixed base plate 501 to removably attach the drug delivery device to the fixed base plate 501 for drug delivery to a patient. In some embodiments, the fixed base plate 501 may position the attached drug delivery device over one or more of the opening 515 or the punctureable portion of one or more elastomeric diaphragms 513s included in the access port 513. In some embodiments, attaching a drug delivery device with the device-side connector 504 disposed in the base-side connector 505 in the fixed base plate 501 may allow one or more drugs to be delivered through the opening 515 through the skin 510 into the diaphragm 513s of the access port 513.

[0450] In some embodiments, a drug delivery device provided with a device-side connector 504 for cooperating with a base-side connector 505 in a fixed base plate 501 may include one or more drug delivery devices such as a needle assembly, a wearable syringe (or infusion device) or an autoinjector (each as described with respect to the example embodiments below) and / or other devices provided with a device-side connector 504 that will be apparent to those skilled in the art.

[0451] Example Implementation: Drug administration using the secured base plate and needle assembly Refer again Figures 5D-1 to 5D-3 And for the purpose of describing the following example embodiment, it is assumed that the access port has been positioned as previously described, the positioning assembly 502 has been removed from the base plate 501, the base plate 501 is provided with the base connector 505, and the opening 515 is disposed on the skin 510 above the punctureable portion of the elastomeric diaphragm 513s, all as previously described. Additionally, the skin 510 may have been as described in the reference... Figure 6B-1 and Figure 6B-2 As described, they are marked and / or disinfected. One or more drug delivery devices equipped with device-side connectors 504 can then be attached to the anchored base plate 501 and deliver drugs to the patient through the skin 510 and septa 513s. For example, a user can then attach one or more different devices having device-side connectors 504 to the base plate connector 505 and thus to the base plate 501, thereby obtaining access to the skin 510, access port 513, or port septa 513s, for example, using an injection needle.

[0452] needle assembly Figure 7AAn example embodiment of a drug delivery device including an injection needle assembly is illustrated. In some embodiments, the injection needle assembly 700 may be provided with a device-side connector 504, and the injection needle assembly can be removably attached to the base-side connector 505 of the base plate 501, which is fixed to the skin 510, once the housing 503, the locator assembly 502, and the device-side connector 504 are removed from the base plate 501. For example, as previously described, the needle assembly 700 can be removably attached to the base plate 501 after the housing 503 containing the locator assembly 502 is removed from the base plate 501.

[0453] In some embodiments, attachment of the needle assembly 700 to the base plate 501 may precede drug delivery to the patient via the access port 513. In some embodiments, attachment of the needle assembly 700 to the base plate 501 may position the needle 701 within the assembly to puncture the patient's skin 510 and elastomeric diaphragm 513s, thereby placing the needle assembly 700, and particularly the tubing 702, in fluid communication with the implantable access port 513.

[0454] Needle assembly housing + material In some embodiments, the needle assembly 700 may include a needle 701, a tube assembly 702, and a device-side connector 704, all contained within a housing 703. The device-side connector 704 may be according to an example embodiment as previously described (e.g., device-side connector 504); and any details relating to the device-side connector herein may apply to example embodiments of the needle assembly 700.

[0455] Needle 701 can be any suitable needle for piercing an elastomeric port diaphragm used with the device. Needle 701 can be a long tubular cross-section having a proximal end 701p in fluid communication with tubing assembly 702 and a pointed distal end 701d. Medications can be administered to the patient through tubing assembly 702 and the needle channel from the proximal end 701p to the distal end 701d. When placed in the access port, fluid can further be delivered from the distal end 701d through the skin into the access port, and then from the port diaphragm through the port conduit to the patient.

[0456] The needle 701 may be made of siliconized rigid medical-grade stainless steel, and the pointed distal end 701d of the needle 701 may optionally be a non-coring design, such as a hollow-hole percutaneous needle with a curved cannula and a deflected pointed end (e.g., a Huber needle), or may have a conventional needle tip with one or more bevels. A portion of the needle 701 may be substantially straight or may be bent along the long axis of the needle to removably insert into an implantable port. The needle and / or needle tip may optionally be protected by a safety mechanism after use to protect the user of the needle assembly 700 from needlestick injury and exposure to bloodborne pathogens.

[0457] Tubing assembly 702 may be provided with connecting fittings, such as Luer or Luer-Lok® connectors, and may be molded from one or more of silicone, PVC, DEHP-free PVC, EVA, HDPE, LDPE, TPU, PTFE, cyclic olefin polymers or copolymers, fluoropolymers, or other suitable flexible materials or combinations thereof. In an example embodiment, the tubing assembly may be extruded, but may be formed by other means of providing sufficient dimensional and tolerance control over the internal drug lumen as described herein. In an example embodiment, the tubing material may be selected to be a material with low leaching and extractability for compounds that may contaminate the drug, and exhibits high biocompatibility with biopharmaceuticals.

[0458] The housing 703 may be configured to allow easy assembly to a base-side connector, such as by means of gripping features 705, which allow the user of the device to simply grip the device.

[0459] How to use In some embodiments, a method of using the device may include: positioning a port using a housing 503 including a locator assembly 502; temporarily placing a base plate 501 onto patient skin 510 above an implantation port 513 with adhesive, wherein an opening 515 is positioned over a punctureable portion of the port 513; disconnecting a device-side connector 504 from a base-side connector 505; removing the housing 503 including the locator assembly 502 from the base plate 501; and subsequently attaching a needle assembly 700 provided with the device-side connector 704 to the fixed base plate 501 via the base-side connector 505.

[0460] refer to Figure 7B-1 The device-side connector 704 of the needle assembly 700 can be oriented to the base connector 505. (See reference) Figure 7B-2 The needle assembly can be advanced 706 toward the base connector 505, thereby maintaining alignment with the base-side connector 505 until the device-side connector 704 engages with the base-side connector 505. For example... Figure 7B-3 As shown, the needle assembly 700 can then be removably attached to the base plate 501 by rotating the needle assembly 707 relative to the fixed base plate 501. As described, the base plate 501, fixed to the skin, resists rotation caused by the needle assembly 700 during assembly. Since the base plate 501 is located above the implantation access port 513, the needle tip of the needle 701, and particularly the distal end 701d, can be positioned for insertion into the positioning port 513, and particularly into a puncturable elastomeric septum.

[0461] In some embodiments, attaching the housing to the base plate unlocks the pin and allows it to be advanced into the port, as in the case of... Figure 7C-1As shown in the illustrated cross-section. In some embodiments, attaching the housing to the base plate automatically engages the pin into the port, as in the case of... Figure 7C-2 As shown in the cross-section illustrated.

[0462] In some embodiments, a needle, fixed to a base plate 501 and advanced through the skin 510 into an elastomeric diaphragm at a port 513, can be used to administer one or more medications to a patient. After administration, the needle assembly 700 can be removed by rotating relative to the base plate, or alternatively, the entire base plate having the needle assembly 700 can be removed as a single unit.

[0463] Example Implementation: Drug administration using a fixed base plate and a wearable syringe Refer again Figures 5D-1 to 5D-3 And for the purpose of describing the following example embodiment, it is assumed that the access port has been positioned as previously described, the positioning assembly 502 has been removed from the base plate 501, the base plate 501 is provided with the base connector 505, and the opening 515 is disposed on the skin 510 above the punctureable portion of the elastomeric diaphragm 513s, all as previously described. Additionally, the skin 510 may have been as described in the reference... Figure 6B-1 and Figure 6B-2 As described, they are marked and / or disinfected. One or more drug delivery devices equipped with device-side connectors 504 can then be attached to the anchored base plate 501 and deliver drugs to the patient through the skin 510 and septa 513s. For example, a user can then attach one or more different devices having device-side connectors 504 to the base plate connector 505 and thus to the base plate 501, thereby obtaining access to the skin 510, access port 513, or port septa 513s, for example, using an injection needle.

[0464] The exemplary embodiments of this disclosure are advantageously applicable to many wearable drug delivery devices. Many drug delivery devices (such as wearable subcutaneous injection devices) use adhesive elements to secure a syringe containing a drug to a patient's skin. Once secured to the skin, the wearable syringe can advance a percutaneous needle into the subcutaneous tissue and deliver one or more drugs to the patient. Wearable syringes can refer in various ways to a drug delivery device worn on the body that typically delivers a fixed dose of drug via injection or infusion (such as via a subcutaneous administration route) within a specified nominal delivery time. Wearable syringes can be referred to in various ways as "wearable" or "patch" devices, "large volume infusion devices (LVIs)," "push syringes," "push infusion devices," "on-body syringes," or "on-body infusion devices." "Wearable syringes" can be characterized by larger volume drug reservoirs supporting larger volumes and powerful actuation mechanisms, or by having longer administration times.

[0465] Many wearable injectors can be combined with the exemplary embodiments of this disclosure, for example, by eliminating adhesive elements and instead providing a device connector as described in the exemplary embodiments herein, and also by replacing the pointed percutaneous needle with a design suitable for the access port, such as a hollow percutaneous needle (e.g., a Huber needle) with a curved cannula and a deflected pointed end, or other needles as described herein. With such a configuration, a wide variety of wearable injectors with the device connector can be attached to the base connector, and thus the base plate can be secured to the patient's skin above the implantable access port positioned using the device described in the exemplary embodiments herein.

[0466] For example, Figure 8A The illustration depicts a wearable injector based on the related technology described in Hooven's U.S. Patent Application Publication No. 2021 / 0338928A1, and more specifically illustrates the bottom 46 of the device, which may be provided with an adhesive to allow the device to be secured to a patient's skin. In the example, the device bottom 46 with adhesive may be eliminated, and instead, a device connector as described according to the example embodiments herein may be provided. Figure 8A The apparatus illustrated herein is provided merely as an example of related technology, which can be combined with the exemplary embodiments described herein, and the embodiments are not limited thereto. Rather, it is merely used to illustrate how exemplary embodiments of this disclosure can be integrated into a wide variety of wearable devices. Some embodiments of this disclosure can be readily applied to other wearable injectors known in the art.

[0467] Figures 8B-1 to 8B-3 The illustration shows a perspective view of an example embodiment of a drug delivery device configured for use with the example embodiments described herein. References Figure 8B-1 The wearable injector 800 may be provided with an integrated device-side connector 801 configured to cooperate with the base plate, as previously described.

[0468] like Figure 8B-2As shown, the device-side connector 801 may also be provided separately to the wearable syringe 800 and attached 806 during manufacturing, such as by gluing, ultrasonic welding, snap-fitting, or other suitable methods. Alternatively, the device-side connector 801 may be provided separately to the wearable syringe 800 and attached 806 by the user of the device (such as a patient or healthcare provider) before use. In either example, once attached, the device-side connector 801 and the wearable syringe 800 can form an integral unit. In either configuration, the device-side connector 801 and the wearable syringe 800 may each have one or more positioning features 802, 803 on the wearable device or the device connector, said one or more positioning features being configured to orient the connector opening 804 relative to the needle opening 805 of the wearable syringe 800, thereby allowing the needle to protrude through the opening 805 as desired.

[0469] like Figure 8B-1 and Figure 8B-3 As seen in the diagram, the connector opening 804 can be positioned relative to the needle opening 805 of the wearable syringe 800 in a manner that allows the needle to protrude downward through the opening 805 when desired (e.g., by pressing down to activate button 807). With this configuration, the needle of the wearable syringe 800 can be used to administer medication through the port when desired. In some embodiments, the connector opening 804 may be provided as a substantially annular member or cavity, thereby allowing the user of the device to more easily attach the wearable syringe 800 to the base-side connector.

[0470] Advantageously, with minor modifications to existing wearable injector designs, this allows wearable injectors (e.g., on-body devices or OBIs) (such as hypodermic syringes) to deliver medication intravenously to the port. This can be further facilitated by replacing the skin puncture needle with a non-cored design suitable for port access (e.g., a hollow-hole percutaneous needle with a curved cannula and a deflected sharp end (e.g., a Huber needle) or other needles described herein). Furthermore, with minor modifications to the wearable injector design, some embodiments of this disclosure can utilize existing features of the device, such as needle insertion safety and needle insertion / retraction features.

[0471] In some embodiments, a wearable syringe with a device-side connector can be removably attached to a base plate fixed to the skin via a base-side connector. Figure 8C-1 and Figure 8C-2 The illustration shows a perspective view of the components of the device during such a process, according to an example embodiment. Figure 8C-1As seen in the diagram, the base plate 820 can be attached to the skin 821 above the implantation port 822, wherein the skin-side connector 824 is oriented away from the skin, as previously described. A wearable syringe 800 having a device-side connector 801 and a device-side opening 804 can be positioned above the skin-side connector 824 and advanced downwards 823. The needle 808 can be held in a retracted or "ready" position within the wearable syringe 800. (Reference) Figure 8C-2 The skin-side connector 824 and the device-side connector 801 can cooperate to engage the wearable syringe 800 onto the base plate 820 attached to the skin 821 (in this example, the threaded connector is engaged by rotating the wearable syringe 800 825).

[0472] In some embodiments, activation of the wearable syringe attached to the base plate allows the injection needle to pierce the patient's skin and the elastomeric diaphragm of the port, thereby placing a drug contained within the wearable syringe into fluid communication with one or more of the implantable access port, port cavity, or catheter. Figure 8D-1A and Figure 8D-1B As shown, the needle 808 of the wearable syringe 800 can be positioned on the septum 822s of the port 822, but has not yet been advanced through the skin 821, tissue 830, or port septum 822s. In other words, the wearable syringe 800 is ready to deliver medication to the port 822 when the user of the device desires it, for example, by pressing the activation button 807.

[0473] In an example embodiment, either or both of the skin-side connector 824 and the device-side connector 801 may cooperate to position either or both of the distal end 808d of the wearable injector 800 and / or the needle 808 at a desired (e.g., predetermined) distance 834 from the patient's skin 821 prior to injection. This arrangement ensures that the needle 808 will penetrate the skin 821 and septum 822s and prevents the wearable injector 800 and needle 808 from migrating or moving during injection, thereby ensuring that the full dose of medicine is delivered to the patient. Figure 8D-2 As shown, pressing down on the activation button 807 causes the distal end (e.g., the tip) of the needle 808 to emerge from the wearable syringe 800, pass through the opening 835 in the base plate 820, through the skin 821 and tissue 830, into the port septum 822s, and into the port cavity 822c, thereby allowing the administration of the medicine in the wearable syringe 800 to the patient via the port catheter 831.

[0474] In some embodiments, after the outer housing 503 containing the locator assembly 502 is removed from the base plate 501 (e.g., after positioning the port and placing the base plate 820 on the skin 821, as previously described), the wearable syringe 800 may be attached to the base plate 820.

[0475] In some embodiments, port positioning may precede the attachment of the wearable device to the base plate secured to the skin, as in the aforementioned example. The wearable syringe and positioning assembly may be separate. In use, the port can be positioned, the positioning assembly removed (secured to the skin), both as previously described, and then the wearable syringe can be assembled to the base plate after port positioning has been performed.

[0476] However, the embodiments are not limited to this, and in some embodiments, the wearable injector may have one or more components (e.g., sensors, controllers, etc.) directly coupled to a port positioning assembly in the injector, along with the base plate previously described. This embodiment can be used to first position the implantation port by moving the assembly over the skin. After the port has been positioned, the base plate can be secured to the port, thus positioning the wearable injector to deliver medication to the patient through the port. This embodiment may be particularly advantageous for electromechanical wearable injectors, which may already be equipped with a power supply, controller, or other features that can be supplemented by the features described herein, such as port sensors, skin sensors, and controllers for detecting port position. This arrangement improves convenience, cost, and reduces the complexity of the previously described multi-step process.

[0477] Example Implementation: Drug administration using a fixed base plate and an autoinjector Refer again Figures 5D-1 to 5D-3 And for the purpose of describing the following example embodiment, it is assumed that the access port has been positioned as previously described, the positioning assembly 502 has been removed from the base plate 501, the base plate 501 is provided with the base connector 505, and the opening 515 is disposed on the skin 510 above the punctureable portion of the elastomeric diaphragm 513s, all as previously described. Additionally, the skin 510 may have been as described in the reference... Figure 6B-1 and Figure 6B-2 As described, they are marked and / or disinfected. One or more drug delivery devices equipped with device-side connectors 504 can then be attached to the anchored base plate 501 and deliver drugs to the patient through the skin 510 and septa 513s. For example, a user can then attach one or more different devices having device-side connectors 504 to the base plate connector 505 and thus to the base plate 501, thereby obtaining access to the skin 510, access port 513, or port septa 513s, for example, using an injection needle.

[0478] Figure 9AThe illustration shows how an autoinjector guide 902, provided with a device-side connector 903 according to an example embodiment, can cooperate with a base-side connector 505 to removably attach the autoinjector guide 902 to a base plate 501, which is adhesively secured to skin 510 above an access port 513 located beneath the implanted skin. Figure 9A As illustrated, the outer housing 503 containing the locator assembly 502 has been removed from the base plate 501, as previously described with reference to the example embodiments in Figures 6A-6C.

[0479] Figure 9A Also illustrated is a perspective view of an example embodiment of a drug delivery device according to an example embodiment, which includes a handheld autoinjector 901 configured for use with an autoinjector guide 902. An autoinjector can refer to a handheld drug delivery device in various ways, which delivers a fixed dose of drug within a specified nominal delivery time. The fixed dose can be, for example, 1-10 mL, with an injection time of 10 seconds to 3-5 minutes, and multiple autoinjectors can be used for a single drug dosing event if desired. Many autoinjectors can be used for delivery of subcutaneous injections, such as injections of biological drugs. The autoinjector can be a single-use, disposable device, or can be provided as a system having one or more reusable components (e.g., a drive mechanism) and one or more single-use components (e.g., a drug reservoir and needle, or a drug cartridge). Figure 9A The examples provided are for illustrative purposes of exemplary embodiments of this disclosure and should not be construed as limiting the use to a particular autoinjector design or injection parameters.

[0480] Figure 9B The diagram shows Figure 9AThe image shows a cross-sectional view of the drug delivery device taken along line AA. This autoinjector 901 may include a drug reservoir 906 (e.g., a pre-filled syringe or cartridge as shown), an actuation mechanism 905, a drug delivery needle 908, and optionally an activation button 909. The autoinjector may be elongated, having a proximal end 901p that is held in the hand and a distal end 901d with a needle 908 oriented toward the skin 510 during drug injection. The needle 908 may be a hypodermic needle, taking the form of a long tubular cross-section of siliconized rigid medical-grade stainless steel. The length of the needle 908 may be selected based on the anatomy of the intended injection site, and in this example, the length may vary from 6 mm to 12.7 mm, although any needle length may be selected. The tip of the needle 908 may be selected to avoid damage to the port septa 513s as previously described, having a sharp distal end or alternatively a curved and deflected non-core tip. In this example, the curved and deflected non-core tip may be a Huber needle tip. The needle and / or needle tip may optionally be protected by a safety mechanism after use to protect the user of the autoinjector 901 from needlestick injury and exposure to bloodborne pathogens. Autoinjectors may include many and varied configurations and features beyond those described herein.

[0481] To perform an injection (such as in a subcutaneous injection) using the autoinjector 901 (e.g., in the absence of the base plate 501 or other features described herein), the user may position the distal end 901d against the skin 510 and activate the autoinjector 901, such as by pressing the button 909 or, if the button 909 is not provided, by holding the proximal end 901p in the hand and pressing the distal end 901d against the skin 510. Upon activation, the autoinjector may advance the needle 908 a fixed distance outward from the distal end 901d into the skin 510. The distance the needle 908 may be advanced may vary depending on the design of the autoinjector 901, the provided needle 908, the pharmacokinetics of the drug in the reservoir 906, the expected patient physiology, or other factors.

[0482] This method can be adaptable to be used with this embodiment (e.g., port positioning device 500) for other types of injections, allowing the autoinjector 901 to deliver an injection through the skin 510 into the septum 513s of the access port 513. In some embodiments, attachment of the autoinjector guide 902 to the base plate 501 positions the distal end 901d of the autoinjector 901 within an opening 515 in the base plate 501 to subsequently puncture the patient's skin 510 and septum 513s, positioning the needle 908 in fluid communication with the septum 513s and the catheter 513c of the implantable access port 513 to deliver the medication to the patient.

[0483] This advantageously allows autoinjectors, when handheld, to deliver injectable medications to a patient properly and without discomfort or clinical training via an access port. If desired, the example embodiments may also allow autoinjectors previously limited to subcutaneous injections through the skin without an implantation port to perform other types of injections, such as injections via an implantation port.

[0484] Introduction to Autoinjector Guide Further reference Figure 9B In some embodiments, the autoinjector guide 902 may be provided with a device-side connector 903 and may be configured to be removably attached to a base plate 501 fixed to the skin 510 via a base-side connector 505. The device-side connector 903 provided on the autoinjector guide 902 may be generally as previously described (e.g., device-side connector 504 of the positioning assembly 502). In some embodiments, the autoinjector guide 902 may be provided as part of a component kit that also includes the port positioning assembly 502 and the base plate 501.

[0485] The autoinjector guide 902 can be provided as a substantially annular component having an outer guide surface 911e and an inner guide surface 911, the inner guide surface including an autoinjector side surface 913 and an optional leading portion 912. This annular design can be advantageously configured to allow a user to directly attach the autoinjector guide 902 to the base-side connector 505 by means of the fixed base plate 501 and / or port positioning assembly 200.

[0486] The outer guide surface 911e may be cylindrical as shown, or may take any other profile or contour. The inner guide surface 911 may optionally be provided with a leader 912 that extends from the autoinjector side surface 915 toward the base side surface 910 to position the autoinjector 901 within and smoothly insert it into the autoinjector guide 902. If provided, the leader 912 may be conical as shown, or may take any other profile or contour, and may also include rounded or chamfered surfaces, particularly at the intersection of the leader 912 and the autoinjector side surface 915. The inclusion, omission, or profile of the leader 912 may be determined based on the autoinjector 901 to be used with the device.

[0487] The internal guide surface 911 may be cylindrical as shown or may take any other profile or contour or combination thereof. For example, the lead portion 912 and the autoinjector contact surface 913 may form a contour combination that cooperates with the distal profile of the autoinjector 901 used with the device 500. The autoinjector side surface 913 may narrow from the autoinjector side surface 915 toward the base side surface 910 (e.g., in a narrowing conical form), or it may narrow and then widen toward the base side surface 910, thereby creating an hourglass profile. This hourglass profile may be advantageous in certain autoinjector designs to prevent unintentional activation. In some embodiments, either or both of the lead portion 912 and the autoinjector side surface 913 may take a section that substantially narrows from the autoinjector side surface 915 to the base side surface 910. In some embodiments, either or both of the lead portion 912 and the autoinjector side surface 913 may take a section that substantially narrows from the autoinjector side surface 915 to the base side surface 910 and then widens. The lead portion 912 and the autoinjector side surface 913 can also be smoothly contoured together to smoothly guide the autoinjector 901 during insertion from the autoinjector side surface 915 to the base side surface 910.

[0488] Insertion of an auto-injector into a guide In an example embodiment, when inserted into the autoinjector guide 902 attached to the base plate 501, the distal end 901d of the autoinjector 901 can position the needle 908 of the autoinjector 901 to perform an injection into the diaphragm 513s of the access port 513 below the base plate 501 when desired by the user of the device.

[0489] In an example embodiment, either or both of the leader 912 and the autoinjector side surface 913 may cooperate to position either or both of the distal end 901d and / or the needle 908 of the autoinjector 901 within the area defined by the opening 515 of the base plate 501. For example, either or both of the leader 912 and the autoinjector side surface 913 may cooperate to position the distal end 901d toward a portion of the opening 515 in the base plate 501. A portion of the opening 515 may include, for example, the center point of the opening 515 or a puncturable portion of the port diaphragm 513s below the opening 515.

[0490] In an example embodiment, either or both of the leader 912 and the autoinjector side surface 913 may cooperate to position either or both of the distal end 901d and / or the needle 908 of the autoinjector 901 at a desired distance from the patient's skin 510 prior to injection using the autoinjector 901. A substantially narrowing section may be taken in the leader 912 and the autoinjector side surface 913 from the autoinjector side surface 915 of the autoinjector guide 902 to the base side surface 910. This narrowing profile may be shaped to cooperate with a distal profile (e.g., by having a matching profile) to axially position the distal end 901d, and in particular the needle 908, at a desired distance from one or more of the skin side surface 512 or the skin 510.

[0491] As the autoinjector 901 is inserted into the guide 902, traveling from the autoinjector side surface 913 toward the base side surface 910, this configuration naturally aligns the distal end 901d toward the opening 515, ultimately positioning the needle 908 of the autoinjector 901 over or on the skin 510 covering the diaphragm 513s, thus allowing subsequent injection into the access port 513. This arrangement ensures that the needle 908 will pierce the skin 510 and diaphragm 513 and prevents the autoinjector 901 and needle 908 from migrating or moving during injection, thereby ensuring the delivery of the full dose of medication to the access port 513. This positioning can be performed before injection is performed using the autoinjector 901, but it can also be performed during the injection process itself, depending on the design of the autoinjector 901.

[0492] The autoinjector guide 902 may also be configured to prevent incorrect insertion of the autoinjector 901 or to allow only the injection end (e.g., 901d) to be inserted into the guide 902. In an example embodiment, either or both of the lead portion 912 and the autoinjector side surface 913 may be profiled and / or sized to allow insertion of the distal end 901d of the autoinjector 901, which has one or more specific distal profiles. In some embodiments, either or both of the lead portion 912 and the autoinjector side surface 913 may be profiled and / or sized to prevent insertion of the proximal end 901p of the autoinjector 901.

[0493] The autoinjector guide 902 can also be configured to restrict or allow the use of a particular autoinjector with the device 500, regardless of its distal end 901d or autoinjector side surface 913. This configuration can help prevent the administration of incorrect or unexpected medications through the access port 513. In some embodiments, either or both of the guide portion 912 and the autoinjector side surface 913 are profiled to allow insertion of an autoinjector 901 having one or more specific distal profiles. In some embodiments, either or both of the guide portion 912 and the autoinjector side surface 913 can be profiled to prevent insertion of an autoinjector 901 having one or more specific distal profiles.

[0494] How to use In an example embodiment, when inserted into the autoinjector guide 902 attached to the base plate 501, the distal end 901d can be positioned to allow the autoinjector 901 to advance the needle 908 through the skin 510 and diaphragm 513s when activated by the user, thereby placing the reservoir 906 in fluid communication with the access port 513 and the conduit 513c.

[0495] In an example embodiment, administering an injection using device 500 may include one or more of the following: attaching an autoinjector guide 902 to a base plate 501 fixed to the patient's skin 510; aligning either or both of the distal end 901d or the distal profile with either or both of the leader 912 or the autoinjector side surface 913; positioning the distal end 901d of the autoinjector 901 within the autoinjector guide 902 close to the skin 510; advancing the distal end 901d toward the skin 510; optionally activating the autoinjector 901; advancing the needle 908 through the skin 510 and the diaphragm 513s; positioning the needle 908 in fluid communication with the access port 513; or delivering a drug from a reservoir 906 via the needle 908.

[0496] Figure 9C An initial configuration of an example embodiment is shown, in which the autoinjector guide 902 is removably attached to the base plate 501. The base plate 501 can be secured to the patient's skin 510, with an opening 515 positioned over an implantable access port 513. The autoinjector guide 902, having a device-side connector 903, can be coaxially positioned over the base-side connector 504 of the base plate 501. The autoinjector guide 902 can be advanced toward the base plate 501 in a direction 920, thereby allowing the device-side connector 903 to connect to the base-side connector 505.

[0497] exist Figures 9C to 9F-2 In the illustrated example, connectors 903 and 505 can form a threaded connection. For example... Figure 9DAs seen in the diagram, the connection can be made by rotating the guide 902 clockwise 921 to thread the device-side connector 903 onto the base-side connector 505 of the base plate 501. In some embodiments, the base plate 501, fixed to the skin, can resist torsional forces caused by rotation of the autoinjector guide 902 and the device-side connector 903 (e.g., clockwise 921 or the opposite counterclockwise direction).

[0498] refer to Figure 9E-1 The autoinjector 901 can be held in the user's hand and advanced 922 from the side surface 911 of the autoinjector towards the base side surface 910 of the autoinjector guide 902, thereby positioning the distal end 901d of the autoinjector 901 closer to the skin 510 within the autoinjector guide 902. Figure 9E-2 As seen in the diagram, during advancement 922, when the distal end 901d approaches the leading portion 912 of the guide 902, the needle 908 can maintain axial alignment with the diaphragm 513s of the access port 513 (e.g., substantially positioned on or centered on the diaphragm).

[0499] refer to Figure 9F-1 and Figure 9F-2 The desired distance from the distal end 901d within the autoinjector guide 902 to the skin 510 can be determined, as previously described, for example, by the arrangement of one or more of the internal guide surface 911, the lead portion 912, and the contact surface 913 of the autoinjector guide 902. After further advancement 923, the autoinjector 901 can remain held by the user, thereby removably inserting into the autoinjector guide 902 located on or near the skin 510 and maintaining axial alignment with the diaphragm 513s of the access port 513.

[0500] refer to Figure 9G The autoinjector 901, now positioned on or near the skin 510 of the diaphragm 513s covering the access port 513, can remain held in the hand and can be activated to perform an injection into the access port 513 when desired by the user. In some embodiments, user activation of the autoinjector 901 may include holding the autoinjector 901 and pressing a button 909, wherein the distal end 901d is enclosed in the autoinjector guide 902. In some embodiments, user activation of the autoinjector 901 may include holding the autoinjector 901 and even pushing the distal end 901d further toward the skin 510 923, while the distal end is enclosed in the autoinjector guide 902.

[0501] When the autoinjector 901 is activated, the needle 908 can be advanced toward the skin 510, thereby sequentially piercing the skin 510, subcutaneous tissue (if present), and port septum 513s, thus positioning it in fluid communication with the access port 513 and the catheter 513c. The actuation mechanism 905 then injects the medication reservoir 906 through the needle into the port 513, ultimately delivering it to the patient via the catheter 513c. In some embodiments, performing the injection may include: activating the autoinjector 901, allowing the needle 908 to sequentially pierce the skin 510 and septum 513s, positioning the reservoir 906 in fluid communication with the access port 513, delivering the medication to the patient via the catheter 513c, and optionally removing the autoinjector 901 from the autoinjector guide 902 after medication delivery is complete.

[0502] The example embodiments described herein can advantageously work with many different common autoinjectors that retract, conceal, or otherwise cover the needle 908 after use. For example, after medication administration is completed, or before or during removal of the autoinjector 901 from the autoinjector guide 902, the needle 908 may retract into or be covered by the autoinjector 901. Such a device may be designed to reduce patient anxiety caused by a visible needle or to prevent accidental needlestick injuries.

[0503] Example Implementation: Method for administering at least one drug to a patient refer to Figure 13 A method 1300 for administering at least one drug to a patient according to an example embodiment may include: determining, using a locator assembly 502 of the device, the location of an access port 513 under the patient's skin. The method may further include: adhering, 1320, a base plate 501 of the device to the patient's skin at a location corresponding to the access port 513; detaching, 1330, the locator assembly 502 from a base connector 505 of the base plate 501 adhered to the skin; and administering, 1340, a first drug to the patient through an opening in the base plate 501 adhered to the skin.

[0504] In some embodiments, administering the first drug to a patient may further include attaching a drug delivery device (also referred to herein as a drug delivery device) to a base connector 505. The drug delivery device may include a support structured to project into an opening in the base plate and restrict detachment of the drug delivery device from the base connector. The drug delivery device may be as described herein—for example, an injection needle assembly 700, a wearable syringe 800, or an autoinjector guide 902—though embodiments are not limited thereto.

[0505] Therefore, in some embodiments, administering the first drug to the patient may further include: attaching the autoinjector guide 902 to the base connector 505; and using the autoinjector 901 having the autoinjector guide 902 to administer the first drug to the patient through an opening in the base plate 501.

[0506] In some embodiments, the method may further include: replacing the needle of the syringe with an autoinjector needle to form the autoinjector 901 before using the autoinjector 901.

[0507] In some embodiments, administering a first drug to a patient may include: attaching a needle assembly 700 to a base connector 505; and using the needle assembly 700 to puncture the patient’s skin through an opening and to puncture an elastomeric diaphragm of an access port, thereby positioning the needle assembly 700 in fluid connection with the access port 513 and administering the first drug to the patient therethrough.

[0508] In some embodiments, administering the first drug to a patient may further include: attaching the wearable syringe 800 to the base connector 505; and causing the protrusion of the needle of the wearable syringe 800 to pierce the patient's skin through an opening and puncture the elastomeric diaphragm of the access port 513, thereby positioning the wearable syringe 800 in fluid connection with the access port 513 and administering the first drug to the patient therethrough.

[0509] In some embodiments, the first drug administered by a drug delivery device as described herein may be part of a drug regimen intended to treat a patient’s condition.

[0510] In some embodiments, the method may further include administering a second drug via or in the presence of a base plate 501. For example, the method may further include administering the second drug subcutaneously or intravenously at another location on the patient's skin.

[0511] In some embodiments, the method may further include: adhering a second base plate to the patient’s skin at a location adjacent to the location of the first base plate 501; and administering a second drug to the patient through an opening in the second base plate.

[0512] In some embodiments, the method may further include disinfecting the patient’s skin exposed by the opening of the base plate 501 with a disinfectant swab before administering the first drug to the patient.

[0513] Example Implementation: Method for administering medication to a patient refer to Figure 14A method 1400 for administering a drug to a patient (e.g., as a protocol) according to an example embodiment may include: administering 1410 a first drug to the patient, including attaching a first drug application device to a base plate 501 adhered to the patient's skin; removing 1420 the first drug application device from the base plate; administering 1430 a second drug to the patient, including attaching a second drug application device to the base plate 501 adhered to the patient's skin; removing 1440 the second drug application device from the base plate 501; administering 1450 a third drug to the patient, including attaching a third drug application device to the base plate 501 adhered to the patient's skin; and removing 1460 the third drug application device from the base plate 501. As described by the examples herein, the base plate 501 may include an adhesive flange and a base connector located on the adhesive flange.

[0514] In some embodiments, the first, second, and third drug delivery devices may be different types of drug delivery devices, as described herein. For example, the drug delivery device may be different from an autoinjector 901, an injection needle assembly 700, or a wearable injector 800, though the embodiments are not limited thereto.

[0515] In some embodiments, at least one of the first, second, or third drug application devices may be attached to a base connector 505 of the base plate 501, and at least one of the other two drug application devices may be attached to a second base connector of the base plate 501.

[0516] In some embodiments, the method may further include administering a fourth drug to a patient, including attaching a fourth drug delivery device to a second base plate adhered to the patient's skin. The second base plate may be adjacent to a base plate 501 on the patient's skin.

[0517] In some embodiments, each of the first, second, and third drug delivery devices may be of the same type. For example, in some embodiments, the same type of drug delivery device may be at least one of an autoinjector 901, an injection needle assembly 700, or a wearable injector 800, but the embodiments are not limited thereto.

[0518] In some embodiments, the first, second, and third drugs may include and / or may be a pharmaceutical regimen for treating a patient's condition, and the method may include administering additional drugs to the patient. The first, second, and third drugs (and additional drugs thereof) may be administered during the same treatment period or over a period of days, weeks, or months.

[0519] In some embodiments, the method may further include: determining the location of the access port 513 under the patient's skin; and adhering the base plate 501 to the patient's skin at a location corresponding to the location of the access port 513.

[0520] In some embodiments, the base plate may include an opening extending through the adhesive flange and the base connector 505, through which at least one of a first, second, or third drug may be administered to the patient.

[0521] In some embodiments, at least one of a first, second, or third drug may be administered subcutaneously to the patient. In this example, although one of the first, second, or third drugs may be administered through an opening in the base plate 501, the embodiments are not limited thereto, and in other embodiments, one or more drugs may be administered through a second location on the patient's skin.

[0522] The methods and systems described herein can be deployed, in part or in whole, by a machine that executes computer software, program code, and / or instructions on a processor. This disclosure can be implemented as a method on a machine, as part of or associated with a machine, or as a computer program product executed on one or more machines and embodied in a computer-readable medium. In embodiments, the processor can be part of a server, cloud server, client, network infrastructure, mobile computing platform, fixed computing platform, or other computing platform. The processor can be any kind of computing or processing device capable of executing program instructions, code, binary instructions, etc. The processor can be or may include a signal processor, digital processor, embedded processor, microprocessor, or any variant such as a coprocessor (mathematical coprocessor, graphics coprocessor, communication coprocessor, etc.), etc., which can directly or indirectly facilitate the execution of program code or program instructions stored thereon. Additionally, the processor can enable the execution of multiple programs, threads, and code. Threads can execute concurrently to enhance processor performance and facilitate simultaneous operation of applications. By implementation, the methods, program code, program instructions, etc., described herein can be implemented in one or more threads. Threads may derive other threads, which may have been assigned priorities associated with them; the processor may execute these threads based on priorities or any other order of instructions provided in the program code. A processor or any machine utilizing a processor may include non-transitory memory that stores methods, code, instructions, and programs as described herein and elsewhere. The processor may access non-transitory storage media, which may store methods, code, and instructions as described herein and elsewhere, through an interface. Storage media associated with the processor for storing methods, programs, code, program instructions, or other types of instructions executable by a computing or processing device may include, but are not limited to, one or more of CD-ROMs, DVDs, memory, hard disks, flash drives, RAM, ROM, cache memory, etc.

[0523] The processor may include one or more cores that can enhance the speed and performance of the multiprocessor. In embodiments, the processor may be a dual-core processor, a quad-core processor, other chip-level multiprocessors, etc., which combine two or more independent cores (referred to as dies).

[0524] The methods and systems described herein can be deployed, in part or in whole, via machines that execute computer software on servers, clients, firewalls, gateways, hubs, routers, or other such computer and / or networking hardware. The software program may be associated with a server, which may include file servers, print servers, domain servers, internet servers, intranet servers, cloud servers, and other variations such as secondary servers, host servers, distributed servers, etc. A server may include one or more of the following: memory, processor, computer-readable transient and / or non-transitory media, storage media, (physical and virtual) ports, communication devices, and interfaces capable of accessing other servers, clients, machines, and devices via wired or wireless media, etc. The methods, programs, or code described herein and elsewhere may be executed by the server. Additionally, other means required to perform the methods described herein may be considered part of the infrastructure associated with the server.

[0525] The server can provide interfaces with other devices, including but not limited to clients, other servers, printers, database servers, print servers, file servers, communication servers, distributed servers, social networks, etc. Additionally, such connections and / or links can facilitate remote execution of programs across networks. Networking some or all of these devices can facilitate parallel processing of programs or methods at one or more locations without departing from the scope of this disclosure. Furthermore, any device attached to the server via the interface can include at least one storage medium capable of storing methods, programs, code, and / or instructions. A central repository can provide program instructions to be executed on different devices. In this embodiment, a remote repository can act as a storage medium for program code, instructions, and programs.

[0526] Software programs may be associated with clients, which may include file clients, print clients, domain clients, internet clients, intranet clients, and other variations such as auxiliary clients, host clients, distributed clients, etc. Clients may include one or more of the following: memory, processor, computer-readable transient and / or non-transitory media, storage media, (physical and virtual) ports, communication devices, and interfaces capable of accessing other clients, servers, machines, and devices via wired or wireless media, etc. The methods, programs, or code described herein and elsewhere may be executed by the client. Additionally, other means required to perform the methods described herein may be considered part of the infrastructure associated with the client.

[0527] The client can provide an interface with other devices, including but not limited to servers, other clients, printers, database servers, print servers, file servers, communication servers, distributed servers, etc. Additionally, such connection and / or linking can facilitate remote execution of programs across a network. Networking some or all of these devices can facilitate parallel processing of programs or methods at one or more locations without departing from the scope of this disclosure. Furthermore, any device attached to the client via the interface can include at least one storage medium capable of storing methods, programs, applications, code, and / or instructions. A central repository can provide program instructions to be executed on different devices. In this embodiment, a remote repository can act as a storage medium for program code, instructions, and programs.

[0528] In embodiments, one or more of the controllers, circuits, systems, data collectors, storage systems, network elements, etc., described throughout this disclosure may be embodied in or on integrated circuits, such as analog, digital, or mixed-signal circuits, such as microprocessors, programmable logic controllers, application-specific integrated circuits, field-programmable gate arrays, or other circuits, such as those embodied on one or more chips disposed on one or more circuit boards, such as those providing one or more of the functions described herein in hardware (with potentially accelerated speed, energy performance, input / output performance, etc.). This may include assembling circuitry with up to billions of logic gates, flip-flops, multiplexers, and other circuitry in a small space, thereby promoting high-speed processing, low power dissipation, and reduced manufacturing costs compared to board-level integration. In embodiments, digital ICs (typically microprocessors, digital signal processors, microcontrollers, etc.) may use Boolean algebra to process digital signals to embody complex logic, such as the complex logic involved in the circuits, controllers, and other systems described herein. In embodiments, the data collector, expert system, storage system, etc., may be embodied as: digital integrated circuits (“ICs”), such as logic ICs, memory chips, interface ICs (e.g., level shifters, serializers, deserializers, etc.), power management ICs, and / or programmable devices; analog integrated circuits, such as linear ICs, RF ICs, etc.; or mixed-signal ICs, such as data acquisition ICs (including A / D converters, D / A converters, digital potentiometers) and / or clock / timing ICs.

[0529] The methods and systems described herein can be deployed, in part or in whole, through a network infrastructure. The network infrastructure may include elements such as computing devices, servers, routers, hubs, firewalls, clients, personal computers, communication devices, routing devices, and other active and passive devices, modules, and / or components as known in the art. Among other components, one or more computing and / or non-computing devices associated with the network infrastructure may also include storage media such as flash memory, buffers, stacks, RAM, ROM, etc. The processes, methods, program code, and instructions described herein and elsewhere may be executed by one or more of the network infrastructure elements. The methods and systems described herein can be configured for use with any kind of private, community, or hybrid cloud computing network or cloud computing environment, including environments involving features of Software as a Service (“SaaS”), Platform as a Service (“PaaS”), and / or Infrastructure as a Service (“IaaS”).

[0530] The methods, program code, and instructions described herein and elsewhere can be implemented on a cellular network having multiple zones. The cellular network can be a frequency division multiple access (“FDMA”) network or a code division multiple access (“CDMA”) network. A cellular network may include mobile devices, cellular sites, base stations, repeaters, antennas, towers, etc. A cellular network can be GSM, GPRS, 3G, EVDO, mesh networks, or other network types.

[0531] The methods, program code, and instructions described herein and elsewhere may be implemented on or through a mobile device. Mobile devices may include navigation devices, cellular phones, mobile phones, mobile personal digital assistants, laptops, PDAs, netbooks, pagers, e-book readers, music players, and the like. Among other components, these devices may also include storage media such as flash memory, buffers, RAM, ROM, and one or more computing devices. The computing devices associated with the mobile device may be enabled to execute program code, methods, and instructions stored thereon. Alternatively, the mobile device may be configured to cooperate with other devices to execute instructions. The mobile device may communicate with a base station that interfaces with a server and is configured to execute program code. The mobile device may communicate on a peer-to-peer network, mesh network, or other communication network. The program code may be stored on a storage medium associated with the server and executed by a computing device embedded within the server. A base station may include computing devices and storage media. The storage device may store program code and instructions executed by the computing device associated with the base station.

[0532] Computer software, program code, and / or instructions may be stored on and / or accessed on machine-readable transient and / or non-transitory media, which may include: computer components, apparatus, and recording media that hold digital data for computation over a period of time; semiconductor storage devices called random access memory (“RAM”); high-capacity storage devices typically used for more permanent storage, such as optical discs, various forms of magnetic storage devices (e.g., hard disks, magnetic tapes, magnetic drums, magnetic cards), and other types; processor registers, cache memory, volatile memory, and non-volatile memory. Memory; optical storage devices, such as CDs and DVDs; removable media, such as flash memory (e.g., USB sticks or keys), floppy disks, magnetic tapes, paper tapes, punched cards, stand-alone RAM disks, zip drives, removable mass storage devices, offline devices, etc.; other computer memory, such as dynamic memory, static memory, read / write storage devices, volatile storage devices, read-only storage devices, random access storage devices, sequential access storage devices, location-addressable storage devices, file-addressable storage devices, content-addressable storage devices, network-attached storage devices, storage area networks, barcodes, magnetic ink, etc.

[0533] The methods and systems described herein can transform physical and / or intangible items from one state to another. The methods and systems described herein can also transform data representing physical and / or intangible items from one state to another.

[0534] The elements described and depicted herein (including those throughout the flowcharts and block diagrams) imply logical boundaries between elements. However, in accordance with software or hardware engineering practice, the depicted elements and their functions may be implemented on a machine using computer-executable transient and / or non-transitory media having a processor capable of executing program instructions stored thereon, as a monolithic software architecture, a stand-alone software module, or a module employing external routines, code, services, etc., or any combination thereof, and all such implementations are within the scope of this disclosure. Examples of such machines may include, but are not limited to, personal digital assistants, laptops, personal computers, mobile phones, other handheld computing devices, medical devices, wired or wireless communication devices, transducers, chips, calculators, satellites, tablet PCs, e-books, gadgets, electronic devices, devices with artificial intelligence, computing devices, networking equipment, servers, routers, and so on. Furthermore, the elements or any other logical components depicted in the flowcharts and block diagrams may be implemented on a machine capable of executing program instructions. Therefore, although the foregoing diagrams and descriptions illustrate functional aspects of the disclosed system, no specific arrangement of the software used to implement these functional aspects should be inferred from these descriptions unless explicitly stated or otherwise clear from the context. Similarly, it will be understood that the various steps identified and described above can be modified, and the order of the steps can be adapted to a specific application of the techniques disclosed herein. All such variations and modifications are intended to fall within the scope of this disclosure. Consequently, the depiction and / or description of the order of the various steps should not be construed as requiring a specific execution order of those steps unless the specific application requires it or explicitly stated or otherwise clear from the context.

[0535] The methods and / or processes described above, and the steps associated therewith, may be implemented in hardware, software, or any combination of hardware and software suitable for a particular application. Hardware may include general-purpose computers and / or special-purpose computing devices, or specific aspects or components of a particular computing device. Processes may be implemented in one or more microprocessors, microcontrollers, embedded microcontrollers, programmable digital signal processors, or other programmable devices together with internal and / or external memory. Processes may also be embodied, or alternatively, in application-specific integrated circuits, programmable gate arrays, programmable array logic, or any other means or combination of means that can be configured to process electronic signals. It will be further understood that one or more of the processes may be implemented as computer-executable code capable of executing on a machine-readable medium.

[0536] Computer-executable code can be created using structured programming languages ​​such as C, object-oriented programming languages ​​such as C++, or any other high- or low-level programming languages ​​(including assembl...

Claims

1. A device for use with an access port implanted in a living organism, the device comprising: Positioner assembly, the positioner assembly comprising: A sensor, configured to sense one aspect of the access port, The aforementioned aspect includes at least two different material densities of the access port; The controller is configured to determine the location of the access port based on the at least two different material densities that distinguish the access port. Wherein, the at least two different material densities correspond to at least two different elements of the access port, including at least one of the port housing or elastomer capable of piercing the port diaphragm; and An output device, configured to provide feedback to the user. The controller is also configured to instruct the output device to provide feedback to the user based on the determined location of the access port.

2. The device according to claim 1, wherein, The access port is a subcutaneous access port.

3. The device according to claim 1, wherein, The access port is structured for subcutaneous or intravenous drug delivery.

4. The device according to claim 1, wherein, The sensor includes multiple ultrasonic (UT) sensors.

5. The device according to claim 1, wherein: The sensor includes a central sensor and a plurality of peripheral sensors arranged in a concentric pattern around the central sensor; and When the locator assembly is positioned over the access port, the central sensor corresponds to the elastomeric piercing port diaphragm, and the plurality of peripheral sensors correspond to the port housing surrounding the elastomeric piercing port diaphragm.

6. The device according to claim 1, wherein, The at least two distinct elements include the port housing and the elastomer-perforable port diaphragm, and the material of the port housing is denser than the material of the elastomer-perforable port diaphragm.

7. The device according to claim 6, wherein, The controller is also configured to identify one or more regions of the elastomer that can puncture the port diaphragm, and wherein each of the regions corresponds to a punctureable diaphragm of a discrete lumen connected to the access port.

8. The device according to claim 6, wherein: Based on sensing from the sensor, the controller is also configured to identify one aspect of the puncturable elastomeric port diaphragm or the port housing; and The aspect includes at least one of geometry, profile, or material.

9. The device according to claim 8, wherein: The controller is also configured to identify at least one of the design, model, or manufacturer of the access port based on the aspects of the port housing.

10. The device according to claim 1, wherein, The output device includes a wireless interface for communicating with a remote device, and the controller is configured to provide the determined location to the remote device via the wireless interface.

11. The device according to claim 10, wherein, The remote device is a smartphone.

12. A system comprising: The device according to claim 10; as well as A non-transitory computer-readable storage medium storing instructions that, when executed by at least one processor of the remote device, comprise: Receive the determined position from the output device; as well as The remote device's display is instructed to provide the feedback to the user in a visual form.

13. The device according to claim 1, wherein, The feedback is at least one of touch, vision, or hearing.

14. The device according to claim 1, wherein: The feedback includes directional feedback; and The controller is also structured to instruct the output device to provide the directional feedback to the user, such that the directional feedback indicates both the direction in which the device moves to directly overlap with the access port and the relative proximity of the access port.

15. The device according to claim 1, wherein, The controller is also configured to detect the orientation of the access port under the skin of the living body based on sensing from the sensor.

16. The device according to claim 15, wherein, The controller is also structured to detect that the orientation of the access port under the skin is inverted based on determining the bottom of the implanted access port's upward orientation toward the skin.

17. The device according to claim 1, further comprising: A base plate having an adhesive for adhesion to the skin of the living organism. The locator assembly and the base plate are configured to be attached to and detached from each other.

18. The device according to claim 17, wherein, The base plate is configured to cooperate with the drug delivery device.

19. The device according to claim 1, wherein, The sensor includes multiple ultrasonic sensors.

20. A method for locating an access port implanted in a living organism, the method comprising: One aspect of the access port is sensed using the sensors of the locator assembly. The aspect includes at least two different material densities of the access port, and the at least two different material densities correspond to at least two different elements of the access port, including at least one of the port housing or elastomer that can puncture the port diaphragm. The location of the access port is determined based on the difference in the density of at least two different materials used in the access port; and Feedback is output to the user based on the determined location of the access port.

21. The method according to claim 20, wherein, Outputting the feedback to the user includes: The system provides directional feedback to the user, which includes both the direction in which the locator component moves to directly overlap with the access port and the relative proximity of the access port.

22. The method according to claim 20, wherein, The step of outputting the feedback to the user includes: The feedback is output to a remote device via a wireless interface.

23. The method of claim 20, wherein, The feedback is provided via the locator component, and the feedback is at least one of tactile, visual, or auditory.

24. A device for use with an access port implanted in a living organism, the device comprising: Positioner assembly, the positioner assembly comprising: At least one port sensor is configured to sense one aspect of the access port; At least one skin sensor is configured to sense the proximity of the device to the skin of the living body; A controller configured to determine the location of the access port based on aspects sensed by the at least one port sensor. The controller instructs the at least one port sensor to sense the aspect based on the proximity of the device to the skin, as sensed by the at least one skin sensor; and An output device, configured to provide feedback to the user. The controller is also configured to instruct the output device to provide the feedback to the user based on the determined location of the access port.

25. The device according to claim 24, wherein: When the at least one skin sensor indicates that the device is more than a predetermined threshold away from the skin, the controller instructs the at least one port sensor to sense the aspect at a first time interval; When the at least one skin sensor indicates that the device is at or within the predetermined threshold relative to the skin, the controller instructs the at least one port sensor to sense the aspect at a second time interval; and The first time interval is slower than the second time interval.

26. The device according to claim 25, wherein, A predetermined threshold distance from the skin corresponds to the height of the access port, taking into account any protrusion of the access port beneath the skin.

27. The device according to claim 25, wherein, The predetermined threshold is between 0.5 inches and 1.0 inches, including the end value.

28. The apparatus according to claim 25, wherein: The first time interval and the second time interval correspond to the sampling rate of the at least one port sensor; The first time interval is at or below a frequency of 500 Hz; and The second time interval is between frequencies between 750 Hz and 1000 Hz, including the endpoints.

29. The device according to claim 25, wherein, As the skin sensor indicates that the distance between the device and the skin is decreasing, the frequency of the second time interval increases.

30. The device according to claim 24, wherein: The at least one skin sensor includes a capacitive sensor and a spring needle; The capacitive sensor senses the proximity of the device to the skin; and The spring needle senses contact with the skin.

31. The device according to claim 30, wherein, The at least one port sensor includes an ultrasonic sensor.

32. The device according to claim 30, wherein, At least one of the capacitive sensor or the spring pin is electromagnetically shielded using a shielding element to prevent electromagnetic interference (EMI) from the spring pin from interfering with the sensing of the capacitive sensor.

33. The device according to claim 30, wherein, The controller controls the power to the spring needle so that contact with the skin is sensed only when the proximity of the device to the skin is within a predetermined threshold.

34. The device according to claim 33, wherein, The predetermined threshold corresponds to the height of the access port to take into account the protrusion of the access port beneath the skin.

35. The device according to claim 24, wherein: The at least one skin sensor includes a capacitive sensor; and The device includes a structure for preventing interference with the sensing of the capacitive sensor.

36. The device according to claim 24, wherein, The output device includes a visual indicator configured to indicate at least one of the direction or proximity of the access port relative to the device.

37. A method for using an access port under the skin of an implanted living organism, the method comprising: The proximity to the skin is sensed using at least one skin sensor of the device; Based on proximity to the skin, at least one port sensor is instructed to sense one aspect of the access port; The access port is sensed using the at least one port sensor; The controller determines the location of the access port based on aspects sensed by the at least one port sensor; as well as Feedback is provided to the user via an output device based on the determined location of the access port.

38. The method according to claim 37, wherein, The proximity of the sensor to the skin also includes: When the at least one skin sensor indicates that the device is more than a predetermined threshold away from the skin, the aspect is sensed at a first time interval; and When the at least one skin sensor indicates that the device is at or within the predetermined threshold relative to the skin, the aspect is sensed at a second time interval. The first time interval is slower than the second time interval.

39. The method according to claim 38, wherein, A predetermined threshold distance from the skin corresponds to the height of the access port, taking into account any protrusion of the access port beneath the skin.

40. The method of claim 38, wherein: The first time interval and the second time interval correspond to the sampling rate of the at least one port sensor; The first time interval is at or below a frequency of 500 Hz; and The second time interval is between frequencies between 750 Hz and 1000 Hz, including the endpoints.

41. The method according to claim 37, wherein, The at least one skin sensor includes a spring needle, and the method further includes controlling the power to the spring needle so that contact with the skin is sensed only when the proximity of the device to the skin is within a predetermined threshold.

42. A device for use with an access port implanted subcutaneously in a living organism, the device comprising: Positioner assembly, the positioner assembly comprising: A port sensor, configured to sense one aspect of the access port; A controller configured to determine the location of the access port based on aspects sensed by the port sensor; and An output device, configured to provide feedback to the user. The controller is further configured to instruct the output device to provide the feedback to the user based on the determined location of the access port. The locator assembly further includes a housing, wherein the controller is located within the housing, and the housing includes a device-side connector; and Base plate, comprising: An adhesive flange configured to adhere the base plate to the skin of the living body, the adhesive flange including at least one opening; and A base connector located on the adhesive flange and including at least one opening is configured to cooperate with the device-side connector such that, through the cooperation of the device-side connector and the base connector, the base plate can be attached to and detached from the locator assembly. When the base plate is attached to the locator assembly, at least one opening of the adhesive flange is aligned with at least one opening of the base connector and the port sensor, such that the port sensor senses an aspect of the access port through at least one opening of the adhesive flange and at least one opening of the base connector.

43. The device of claim 42, wherein the locator assembly further comprises: A skin sensor configured to sense the proximity of the device to the skin through at least one opening of the adhesive flange and at least one opening of the base connector.

44. The device according to claim 43, wherein, The skin sensor includes at least one spring needle.

45. The device according to claim 42, further comprising: A skin sensor configured to sense proximity between the device and the skin, wherein the skin sensor includes at least one spring needle, and wherein the base plate includes at least one through-hole for the spring needle to extend through it and sense contact with the skin of the living body.

46. ​​The device according to claim 42, wherein, The base connector is configured to cooperate with a connector of at least one drug delivery device.

47. The device according to claim 46, wherein, The drug delivery device includes at least one of a needle assembly, an autoinjector, or a wearable injector.

48. The device according to claim 42, wherein, The device-side connector and the base connector each have a cylindrical shape and are structured to cooperate threadedly with each other.

49. The device according to claim 42, further comprising: A marking device, which is structured to be placed through an opening in the base plate to mark the skin.

50. The device according to claim 42, further comprising: A disinfectant swab, which is structured to be placed through an opening in the base plate for disinfecting the skin.

51. The device according to claim 42, wherein: The base connector is made of a flexible material and includes a plurality of flexible fingers; and The device-side connector includes a protruding groove. The plurality of flexible fingers and the protruding groove cooperate with each other to attach the base connector to the device-side connector and to detach the base connector from the device-side connector.

52. The device according to claim 51, wherein, The plurality of flexible fingers of the base connector are configured to cooperate with the support of the drug delivery device to restrict the removal of the drug delivery device from the base plate.

53. The device according to claim 42, wherein, The controller is also configured to determine incompatibility between the baseboard and the access port based on the sensed aspects of the port sensor, and wherein the feedback includes an indication of the incompatibility.

54. The device according to claim 53, wherein, The controller determines that the baseboard has the incompatibility based on the identified manufacturer of the access port.

55. The device according to claim 42, wherein, The base connector is configured to work only with access ports manufactured by a predetermined manufacturer.

56. The device according to claim 42, wherein, The bottom side of the locator assembly includes a port recessed area to accommodate the protrusion of the access port beneath the skin.

57. The device according to claim 42, wherein: The locator assembly includes multiple skin sensors; and The at least one opening of the adhesive flange includes a plurality of openings corresponding to the plurality of skin sensors so that the plurality of skin sensors pass through it to sense the skin.

58. A locator assembly for use with an access port implanted in a living organism, the locator assembly comprising: A port sensor, configured to sense one aspect of the access port; A controller configured to determine the location of the access port based on aspects sensed by the port sensor; as well as An output device, configured to provide feedback to the user. The controller is further configured to instruct the output device to provide the feedback to the user based on the determined location of the access port. The positioner assembly also includes a housing, wherein the controller is located within the housing, the housing including a device-side connector configured to attach to and detach from a base plate.

59. The locator assembly of claim 58, further comprising: A skin sensor is configured to sense the proximity of the locator assembly through at least one opening in the base plate.

60. The locator assembly of claim 59, wherein, The skin sensor includes at least one spring needle.

61. The locator assembly of claim 58, wherein, The device-side connector has a cylindrical shape and is structured to thread with the base connector.

62. The locator assembly of claim 58, wherein, The device side connector includes a protruding groove.

63. A device for use with an access port implanted in a living organism, the device comprising: Base plate, comprising: Adhesive flange; and A base connector located on the adhesive flange, the base connector including an opening and an attachment configuration for attaching and detaching with a plurality of components, the plurality of components including a locator assembly for positioning the access port.

64. The device according to claim 63, wherein, The base connector includes a threaded connection that surrounds the opening.

65. The device according to claim 63, wherein, The attachment configuration includes a plurality of flexible fingers surrounding the opening.

66. The apparatus of claim 65, further comprising: A drug delivery device including a device connector having a protruding groove, wherein the plurality of flexible fingers of the attachment configuration interact with the protruding groove to attach the base connector of the base plate to the device connector of the drug delivery device and to detach the base connector from the device connector.

67. The device according to claim 66, wherein, The device connector also includes a tapered support configured to insert into an opening in the base connector when the base plate is attached to the device connector and to prevent or resist inward bending of the plurality of flexible fingers, thereby preventing or resisting detachment of the base connector from the device connector.

68. The device according to claim 63, wherein, The adhesive flange is made of a flexible material.

69. The device according to claim 68, wherein, The base connector is made of a rigid material.

70. The device according to claim 69, wherein, The base connector and the adhesive flange are co-molded during manufacturing to produce a one-piece base plate.

71. The device according to claim 68, wherein, The base connector is made of a flexible material.

72. The device according to claim 63, wherein, The adhesive flange includes an adhesive layer and an adhesive backing, the adhesive layer being configured to adhere to the skin of the living organism when the adhesive backing is removed.

73. The device according to claim 72, wherein, The adhesive backing is folded to form a top half that contacts the adhesive layer and a bottom half that includes a pull tab for removing the adhesive backing from the adhesive layer.

74. The device according to claim 72, wherein, The adhesive flange, which includes the adhesive layer and the adhesive backing, includes at least one through-hole so that a spring needle can extend through it and sense contact with the skin of the living body.

75. The device according to claim 63, wherein, The adhesive flange includes an opening corresponding to the opening of the base connector.

76. The device according to claim 63, wherein, The base plate includes a port relief region, which is structured to accommodate a protrusion of the access port beneath the skin of the living organism.

77. A method for accessing an access port implanted in a living organism, the method comprising: The base plate is positioned above the access port, wherein the base plate includes: Adhesive flange; and A base connector located on the adhesive flange, the base connector including an opening and an attachment configuration for attaching and detaching with a plurality of components, the plurality of components including a locator assembly for determining the position of the access port; and The base plate is adhered to the location of the access port such that the opening of the base connector corresponds to the punctureable elastomeric diaphragm of the access port.

78. The method according to claim 77, wherein, The adhesion of the base plate also includes: Remove the adhesive backing from the adhesive layer of the base plate, wherein the adhesive backing is folded to form a top half that contacts the adhesive layer and a bottom half that includes a pull tab for removing the adhesive backing from the adhesive layer.

79. The method of claim 77, further comprising: The location of the access port is determined using the locator component.

80. The method of claim 79, further comprising: After the base plate is attached, the base plate is removed from the locator assembly.

81. The method according to claim 77, wherein, At least one of the plurality of components is a drug application device, and the method further includes attaching the drug application device to the base connector of the base plate.

82. A method for administering at least one drug to a patient, the method comprising: The location of the access port under the patient's skin is determined using the device's locator assembly; The base plate of the device is adhered to the patient's skin at a location corresponding to the access port. The locator assembly is detached from the base connector of the base plate adhered to the skin; and The first drug is administered to the patient through an opening in the base plate that adheres to the skin.

83. The method according to claim 82, wherein, The administration of the first drug to the patient further includes: The drug application device is attached to the base connector. The drug application device includes a support member structured to protrude into an opening in the base plate and restrict the disassembly of the drug application device from the base connector.

84. The method according to claim 82, wherein, The administration of the first drug to the patient further includes: Attach the auto-injector guide to the base connector; and An autoinjector with the autoinjector guide is used to administer the first drug to the patient through an opening in the base plate.

85. The method of claim 84, further comprising: Before using the autoinjector, the needle of the syringe is replaced with an autoinjector needle to form the autoinjector.

86. The method according to claim 82, wherein, The administration of the first drug to the patient further includes: Attach the injection needle assembly to the base connector; and The injection needle assembly is used to puncture the patient's skin through the opening and to puncture the elastomeric diaphragm of the access port, thereby positioning the injection needle assembly in fluid connection with the access port and administering the first drug to the patient therethrough.

87. The method according to claim 82, wherein, The administration of the first drug to the patient further includes: Attach the wearable syringe to the base connector; and The protrusion of the needle of the wearable syringe is caused to pierce the patient's skin through the opening and penetrate the elastomeric diaphragm of the access port, thereby positioning the wearable syringe in fluid connection with the access port and administering the first drug to the patient therethrough.

88. The method of claim 82, further comprising: The second base plate is adhered to the patient's skin at a location adjacent to the first base plate. as well as The second drug is administered to the patient through an opening in the second base plate.

89. The method of claim 82, further comprising: Before administering the first drug to the patient, the patient's skin exposed through the opening in the base plate is disinfected with a disinfectant swab.

90. A method for administering a drug to a patient, the method comprising: Administering a first drug to the patient includes attaching a first drug delivery device to a base plate that adheres to the patient's skin; Remove the first drug application device from the base plate; Administering a second drug to the patient includes attaching a second drug delivery device to a base plate that adheres to the patient's skin; Remove the second drug delivery device from the base plate; Administering a third drug to the patient includes attaching a third drug delivery device to a base plate that adheres to the patient's skin; as well as Remove the third drug delivery device from the base plate. The base plate includes an adhesive flange and a base connector located on the adhesive flange.

91. The method according to claim 90, wherein, The first, second and third drug application devices are different types of drug application devices.

92. The method according to claim 90, wherein, At least one of the first, second, or third drug application devices is attached to the base connector of the base plate, and at least one of the other two drug application devices is attached to a second base connector of the base plate.

93. The method of claim 90, further comprising: Administering a fourth drug to the patient includes attaching a fourth drug application device to a second base plate adhered to the patient's skin, wherein the second base plate is adjacent to the base plate on the patient's skin.

94. The method according to claim 90, wherein, Each of the first, second, and third drug application devices is of the same type.

95. The method according to claim 94, wherein, The same type of drug delivery device is at least one of an auto-injector, a needle assembly, or a wearable injector.

96. The method according to claim 90, wherein, The first, second, and third drugs comprise a treatment regimen for the patient's condition.

97. The method of claim 90, further comprising: Determine the location of the access port beneath the patient's skin; as well as The base plate is adhered to the patient's skin at a location corresponding to the access port.

98. The method according to claim 90, wherein, The base plate includes an opening extending through the adhesive flange and the base connector, and at least one of the first, second, or third drugs is administered to the patient via the opening.

99. The method according to claim 90, wherein, At least one of the first, second, or third drugs is administered subcutaneously to the patient.

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