Needle guide

Abstract

A needle guide configured to provide a placement guide of a needle of a medicament delivery device onto a medicament delivery site, the needle guide comprising: a body configured to be removably attached to the medicament delivery site; a needle hub configured to be operably connected to a needle of the medicament delivery device such that the needle of the medicament delivery device is attached to the medicament delivery site via the needle hub; an electronic unit attached to the main body of the needle guide; wherein the electronic unit comprises an indicator configured to provide at least one of visual, audible and tactile indications to a user of the medicament delivery device.

Description

Technical Field

[0001] This disclosure relates in its entirety to a needle guide configured to guide a needle of a drug delivery device onto a drug delivery site. Background Technology

[0002] Infusion and injection are common medical procedures for delivering multiple therapeutic agents for a variety of diseases. The terms “infusion,” “injection,” and “administration” are used interchangeably, and the routes of administration—subcutaneous (SC), intramuscular (IM), intravenous (IV), enteral, or others—are also used interchangeably. The route of administration is based on the specific drug’s pharmacokinetic (PK) characteristics, formulation components, approved regulatory labeling, individual clinical judgment, or clinical necessity.

[0003] The subcutaneous injection (SC) route is frequently used for administration of smaller volumes using pre-filled syringes and autoinjectors. Biologics are commonly administered via these devices. SC administration is generally considered less invasive and simpler to administer to patients, particularly compared to intravenous (IV) administration. Additionally, due to the slower physiological uptake of drugs via the SC route, there is potential for improved tolerability compared to IV administration.

[0004] Given these significant advantages in safety, tolerability, and convenience, the pharmaceutical industry has invested heavily in shifting formulations from intravenous (IV) administration to subcutaneous (SC) administration and from clinics to home settings. However, the advancements in large-volume SC (LVSC) administration (subcutaneous administration of more than 3 ml of drug) have introduced several challenges related to tolerability of large volumes of single-drug therapy and the pharmacokinetic effects when large amounts of LVSC are administered sequentially or simultaneously.

[0005] Some biological drugs must be administered in larger volumes than the capacity of pre-filled syringes and autoinjectors. For these drugs, larger-volume devices are used, such as body-worn syringes (OBI, also known as large-volume infusion sets, “LVI”, or push-in syringes) or pump and SC needle assemblies. Such SC needle assemblies consist of a hollow needle with a sharp tip for percutaneous access to the patient’s anatomy, and tubing for connection to the pump. Each needle can be used to deliver a specific volume of drug subcutaneously, which is limited by the patient’s anatomy. For some medium-volume drugs that are infused relatively slowly, a single needle may suffice, as in the case of an OBI device. For other drugs with relatively large volumes, 2–8 needles may be used, with the number of needles typically increasing with the total drug volume and / or infusion rate. Multiple needles can be connected to a shunt, which allows a single drug reservoir driven by a single pump to shunt the drug flow between the drug administration needles.

[0006] The required number of medication administration needles must be inserted by a healthcare provider, the patient themselves, or a non-specialist (i.e., untrained) caregiver. They must consider proper anatomical placement, avoiding scarred areas, areas of broken skin, and certain anatomical sites such as the umbilicus. Additionally, the tubing used to connect each needle set to the shunt or medication reservoir must be carefully managed and is prone to tangling. When one needle set is tangled with another, it is often difficult to attach that set, making the process frustrating and confusing for untrained users, such as the patient themselves. The application process can be particularly clumsy and confusing for untrained or non-clinical users.

[0007] The situation becomes more complex when multiple medications are administered. Several studies have outlined the physiological effects of injecting larger volumes into the SC (skin fossa). These data suggest that the size of the SC drug reservoir and the corresponding skin “wheals” or bumps depend on injection volume, rate, viscosity, inter-individual variability, and other potential factors. Notably, previous clinical studies reported in peer-reviewed literature have focused on single-drug injections. When multiple medications are present, clinicians or pharmaceutical companies wish to administer them sequentially or simultaneously to multiple injection sites while preventing unintentional mixing or diffusion between sites during administration. The science behind this phenomenon may not be predictable beforehand for pharmaceutical companies or intuitively for those lacking clinical training, such as patients themselves or non-specialist caregivers. However, this phenomenon is strongly dependent on needle placement, particularly the relative placement of needles on the skin. Therefore, it is necessary to guide users to place needles sufficiently far apart from each other and / or in a specific order. Summary of the Invention

[0008] This invention is defined by the appended claims, and reference should now be made to the appended claims.

[0009] Therefore, a needle guide is provided, configured to provide a placement guide for a needle of a drug delivery device to a drug delivery site. The needle guide includes: a body configured to be removably attached to the drug delivery site; a needle hub configured to be operatively connected to a needle of the drug delivery device such that the needle of the drug delivery device is attached to the drug delivery site via the needle hub; and an electronic unit attached to the body of the needle guide. The electronic unit includes an indicator configured to provide a user of the drug delivery device with at least one of visual, auditory, and tactile indications to indicate information related to needle placement and / or the position of the needle guide and / or the operation of the drug delivery device.

[0010] The needle guide is configured to guide the needles of the drug delivery device to be placed onto the user's skin. In one example, the needle guide is used to guide multiple needles of the drug delivery device. In this example, the indicator of the needle guide is configured to provide guidance to the user to place the multiple needles of the drug delivery device at a distance spaced apart from each other. The size of this distance is set such that subcutaneous mixing of the drug administered by one needle and another is prevented and / or the diameter of the expected skin wheal to form subcutaneously due to administration of the drug from one needle and the diameter of the expected skin wheal to form subcutaneously due to administration of the drug from another needle is prevented. In another example, multiple needle guides are used. In this example, each of the multiple needle guides is configured to be operatively connected to one needle of the drug delivery device. In this example, the needle guide indicator is configured to provide instructions to the user to place multiple needles of the drug delivery device at a distance from each other, the size of which is set such that subcutaneous mixing of the drug administered by one needle and another needle is prevented and / or the diameter of the expected skin wheal to form subcutaneously due to administration of the drug from one needle and the diameter of the expected skin wheal to form subcutaneously due to administration of the drug from another needle is prevented.

[0011] In another aspect of the invention, a needle guide is provided. The needle guide is configured to provide a placement guide for a needle of a drug delivery device to a drug delivery site. The needle guide includes: a body configured to be removably attached to the drug delivery site; a needle hub configured to be operatively connected to a needle of the drug delivery device; and an electronic unit attached to the body of the needle guide. The electronic unit includes a position detector configured to detect the position of another needle guide relative to the electronic unit, such that the two needle guides can be guided to be spaced apart from each other by a predetermined distance. In this example, the electronic unit of the needle guide may include an indicator as mentioned in previous examples. Alternatively, the electronic unit of the needle guide may not need to include an indicator. For example, the detected position may be transmitted to and displayed on a remote computing device.

[0012] Therefore, needle guides can provide simultaneous injection of multiple needles while ensuring that the needles are properly spaced apart. This typically means that a safe distance can be set between different medications. Thus, the interval between the first and second needles provided by the needle spacer device can be designed based on predefined medication administration.

[0013] "Skin wheals" are subcutaneous accumulations of liquid medications that have diffused radially outward from the injection site during administration and are not immediately absorbed by the body. Skin wheal overlap is a common problem with the administration of large molecule and / or high-volume medications; in other words, small-volume and / or low-molecule medications, such as insulin and / or glucagon injections, do not present this problem because insulin and / or glucagon injections are typically small-volume injections. Insulin vials and pens usually have a concentration of 100 units per 1 mL (100 units / mL), known as U-100, and patients are typically instructed to take 1-3 units of insulin per injection. Therefore, insulin injections are typically small in volume, such as 0.01 mL-0.03 mL.

[0014] Therefore, the needle guide disclosed herein is configured for use with high-volume drug delivery. For example, the amount of the first predefined drug delivered is greater than 1 ml, preferably greater than 3 ml; the amount of the second predefined drug delivered is greater than 1 ml, preferably greater than 3 ml. Furthermore, the sum of the amounts of the first and second predefined drugs delivered is greater than 10 ml, preferably greater than 25 ml. Alternatively, the injection assembly is configured for delivering macromolecular drugs. The biopharmaceutical (a protein with therapeutic effects) is extracted from or adapted from a living organism, such as through genetic engineering, and has a relatively high molecular weight of 1 kilodaltons (kDa) to 1000 kDa. For example, the molecular weight of the first predefined drug is greater than 1 kDa, and / or the molecular weight of the second predefined drug is greater than 1 kDa.

[0015] The needle guide disclosed herein can provide dissociation of subcutaneous reservoirs based on the properties of the drug, infusion parameters for each drug, physiological parameters, or combinations thereof. Combinations of these factors can affect the shape, size, and growth rate of the subcutaneous reservoir. The subcutaneous reservoir, in turn, can affect the pharmacokinetics of drugs injected using this device.

[0016] This is especially important when using different drugs, which is common in cancer treatment regimens. Small molecules and macromolecules can be administered in different sequences, and it is clinically important to prevent mixing or overlapping of subcutaneous reservoirs under the skin to achieve appropriate therapeutic effects.

[0017] The properties of a drug can include whether it is a small or large molecule, its concentration, viscosity, and the presence of dispersants such as hyaluronidase. Characteristic infusion parameters can include infusion rate, volume, viscosity, and non-Newtonian behavior (such as shear thinning or thickening). Infusion parameters can also relate to the device used to infuse the drug into the skin, such as a steel needle or soft cannula, the length or inner diameter of the injection cannula, or its construction material. It is generally desirable to infuse the drug at the highest possible rate within physiological constraints. These factors, in conjunction with physiological constraints, influence the maximum possible delivery rate of the drug delivery device. Physiological parameters can include absorption, bioavailability, subcutaneous thickness, skin fullness, tissue back pressure in response to infusion, and other factors.

[0018] Although presented here as independent factors, many factors may be related. Given knowledge of the properties of the drug (e.g., through laboratory characterization and simulated injection), the infusion parameters for each drug (e.g., through human testing and SC reservoir characterization), and physiological parameters (e.g., through pharmacokinetic and / or pharmacodynamic human studies or computer modeling), the design parameters for each needle spacer can be selected to avoid undesirable mixing or overlap. Different factors may be of interest for each drug.

[0019] Predefined drug administration means that a predefined type of drug / agent will be administered at a predefined rate for a predefined duration. The target patient group is also predefined. This typically means that the expected size of the skin wheals is relatively well-defined, especially when variations in skin wheal size based on the absorption capacity of various users have already been taken into account.

[0020] Each needle disclosed herein may be, for example, a right-angle needle, a straight needle, or a soft cannula, or a soft cannula having an insertion needle configured to penetrate the user's skin. It should be noted that most insertion needles used with soft cannulas will be removed after penetration; therefore, only the soft cannula remains in the user's body during the drug delivery procedure.

[0021] In this disclosure, when the term "distal direction" is used, it refers to a direction pointing away from the dose delivery site during use of the drug delivery device. When the term "distal portion / distal end" is used, it refers to the portion / end of the delivery device or the portion / end of a component of the delivery device that is positioned furthest from the dose delivery site during use of the drug delivery device.

[0022] Accordingly, when the term "proximal direction" is used, it refers to the direction toward the dose delivery site during the use of the drug delivery device.

[0023] When the term “proximal portion / proximal end” is used, it refers to the portion / end of the delivery device or the part / end of the component of the delivery device that is positioned closest to the dose delivery site during use of the drug delivery device.

[0024] In addition, the terms “longitudinal,” “longitudinally,” “axially,” and “axial” refer to the direction of extension from the proximal end to the distal end, typically along the longest extension direction of the device or its components.

[0025] Similarly, the terms "lateral," "transverse," and "laterally" refer to a direction that is approximately perpendicular to the longitudinal direction.

[0026] In addition, the terms “circumferential,” “circumferential,” or “circumferentially” refer to the circumferential or circumferential direction relative to an axis, which is typically the central axis extending in the longest extension direction of the device and / or component.

[0027] Similarly, "radial" or "radially" refers to a direction that extends radially relative to the axis, and "rotational," "rotating," and "rotationally" refer to rotation relative to the axis.

[0028] According to one implementation, the electronic unit is removably attached to the body of the needle guide.

[0029] According to one embodiment, the electronic unit includes a communication unit configured to communicate wirelessly with another pin guide.

[0030] According to one implementation, the location detector includes a communication unit.

[0031] According to one embodiment, the electronic unit includes a processor configured to calculate the position of another pin guide relative to the electronic unit based on signals sent / received by the communication unit.

[0032] According to one implementation, the calculated position is based on one or more of the following: received signal strength, angle of arrival of the received signal, angle of departure of the signal transmitted by the communication unit, or unique pin guide identifier for transmission and / or reception.

[0033] According to one embodiment, the position detector includes a proximity sensor configured to detect the position of another pin guide.

[0034] According to one embodiment, the electronic unit includes a communication unit configured to communicate wirelessly with the drug delivery device.

[0035] According to one embodiment, the body of the needle guide includes a plurality of needle hubs configured to be operatively connected to a plurality of needles of a drug delivery device.

[0036] According to one embodiment, the electronic unit includes multiple indicators. The multiple indicators are respectively positioned next to multiple needle holders.

[0037] According to one embodiment, at least one of the plurality of indicators is configured to provide an indication different from the other plurality of indicators, such that the plurality of indicators are configured to indicate to the user the placement order of the plurality of needles of the drug delivery device.

[0038] According to one embodiment, the body of the needle guide includes a tube seat configured to attach to a tube of a drug delivery device, the tube connecting the needle and the drug container of the drug delivery device.

[0039] According to one embodiment, the electronic unit includes a connection sensor configured to detect that the needle is operatively mounted to the needle hub of the needle guide.

[0040] According to one embodiment, the communication unit is configured to send a signal to another needle guide in response to the detection of a connection sensor on the needle guide, such that an indicator on the other needle guide responds to the signal to provide an indication.

[0041] According to one embodiment, the electronic unit includes a skin sensor configured to detect when the body of the needle guide is attached to the drug delivery site.

[0042] According to one implementation, the indicator is configured to provide indication in response to the position of another pin guide.

[0043] According to one embodiment, the electronic unit includes a proximity sensor configured to detect the position of another needle guide.

[0044] According to one embodiment, the electronic unit includes a processor configured to calculate the position of another pin guide relative to the electronic unit based on signals sent / received by the communication unit.

[0045] According to one implementation, at least a portion of the circuitry of the electronic unit is made of conductive ink.

[0046] According to one implementation, the subject can be circular, elliptical, or have another shape, such as a polygon.

[0047] Alternatively or additionally, according to one embodiment, the needle guide includes a wearable feature configured to be worn by a user.

[0048] As an example, wearable elements are belts, shoulder straps, ties, clothing, leg warmers, or belt clips.

[0049] In addition, the needle guide includes an opening and / or a guide wall to guide the placement of the needle. The opening and / or guide wall are configured to provide a guiding surface.

[0050] According to one embodiment, the needle guide includes a first guide surface and a second guide surface. The first guide surface (or a portion thereof) matches the color of the first needle and / or a first patch connected to the first needle, and the second guide surface (or a portion thereof) matches the color of the second needle and / or a second patch connected to the second needle.

[0051] This provides color cues to facilitate the placement of the first and second spacer elements. The color cues can be selected so that the set of colors can be reliably identified and distinguished by people with or without color blindness.

[0052] Furthermore, since drug delivery devices configured to deliver large volumes of medication to a user are typically placed at a distance from the delivery site—for example, an infusion pump might be placed 1-2 meters from the user's skin—the user is usually instructed to place the first and second needles at the delivery site using a first needle spacer element and a second needle spacer element, respectively, before connecting one or more tubes between the needle and the drug delivery device. In this example, the user may be instructed to mark the needle spacer element with a color matching the color cues on the guide surface, for example, by coloring it with a pen or sticker. Therefore, after removing the needle guide, the user can be further instructed to connect the tubes between the drug delivery device and the needle in the correct manner. For example, the user may be instructed to connect a blue tube to a blue-colored needle guide.

[0053] According to one embodiment, the needle guide includes a through opening defining the location of an anatomical reference point.

[0054] Users can locate the anatomical reference point, for example, by using their fingers through the opening. The needles do not need to be angularly spaced from the anatomical reference point and can be positioned symmetrically, asymmetrically, or in combination along the axis. When using multiple needles for large-volume subcutaneous deliveries, two, three, or four needles may be required, oriented radially towards each other and centered on the anatomical reference point.

[0055] According to one embodiment, the needle guide is shaped to attach to the abdomen, with the anatomical reference point being the navel, or to attach to the leg, with the anatomical reference point being the knee.

[0056] According to one implementation, the needle guide is shaped to attach to the abdomen, with the anatomical reference point being the navel, or to the leg, with the anatomical reference point being the knee. For example, the guide is intended for use on elongated oval sites on the abdomen and thigh. While other shapes for each guide are obviously possible, the size and shape of each guide should give the user a negative cue regarding placing the guide in the opposite position. For example, placing an abdominal guide on top of the thigh might undesirably wrap around the groin or extend above the bend of the knee, both of which indicate to the user that this is not the correct application.

[0057] The shape of the needle guide may suggest, for example, an anatomical placement on the abdomen, and in such cases would be clearly unsuitable for injection sites on the thigh or back of the arm. Including or omitting a positional through-hole can also provide a strong form-based signal to the user of the injection component. Including a positional through-hole may be advantageous for some anatomical reference points (such as the umbilicus), but may be undesirable for other sites (such as the upper thigh or back of the arm). In these latter cases, the needle guide can be placed on the skin at the desired anatomical location and can be positioned more accurately by using other features (such as notches for the shoulder or top of the knee) instead of a positional through-hole. Other features can be provided based on the desired site and the patient's anatomy. Features can also suggest (i.e., encourage) the desired anatomical site, or alternatively, can be outlined to prevent undesired anatomical sites.

[0058] According to one embodiment, the needle guide has a shape that is symmetrical with respect to the position through the opening, or a shape that is asymmetrical with respect to the position through the opening.

[0059] According to one embodiment, the needle guide includes an adhesive surface configured to removably attach to the user's skin.

[0060] According to one embodiment, the needle guide includes an adhesive material disposed on the inner surface of the needle guide and configured to be removably attached to the user's skin.

[0061] According to one embodiment, the needle guide includes a multilayer adhesive material disposed on the inner surface of the needle guide and configured to be removably attached to the user's skin.

[0062] According to one embodiment, the needle guide is reusable. In this example, one layer of the multilayer adhesive material is configured to be removably attached to the user's skin, and the layer attached to the user's skin is configured to be removed from the needle guide after use of the needle assembly.

[0063] Alternatively, according to one embodiment, the needle guide is configured to be removably attached to the user's skin by being held on the skin by the user.

[0064] The needle guide according to any example disclosed herein may be a flexible sheath. The needle guide may include, for example, polymeric materials (such as elastomeric materials (e.g., rubber or silicone rubber)), biopolymeric materials (such as cellulose), compliant open-cell or closed-cell foam materials, or other suitable materials.

[0065] According to one implementation, the pin holder is a hook-and-loop fastener.

[0066] As mentioned above, drug delivery devices used for large-volume drug delivery can be located away from the drug delivery site and use a tube to connect the needle and the drug delivery device. Therefore, there is a risk that the user may accidentally pull the tube while using the drug delivery device. The fastener between the needle hub and the reverse needle hub provides a safety mechanism to prevent the needle from being pulled when the user accidentally pulls the tube. Therefore, the user is protected from needle injury.

[0067] According to one example, the needle guide includes a dispensing hub fluidly connected to a drug delivery device. A tube is connected to the dispensing hub and at least one of a first needle and a second needle.

[0068] According to one example, the needle guide includes a tubing management hub configured to retain a tube connected to a drug delivery device.

[0069] As an example, the fitting management hub is attached to the needle guide.

[0070] According to one example, a drug delivery device configured for use with the needle guide disclosed herein may be an infusion pump.

[0071] As an example, the infusion pump can be a pneumatic pump, a piston pump, or a peristaltic pump.

[0072] According to one example, the infusion pump is configured to continuously deliver drug volumes greater than 25 ml.

[0073] According to one example, an infusion pump may contain more than one type of medication.

[0074] According to one example, the medication delivery device includes a medication container configured to hold a medication. The medication container is a collapsible bag.

[0075] According to one example, a drug delivery device includes more than one drug container.

[0076] Generally, unless otherwise expressly defined herein, all terms used in the claims shall be interpreted according to their ordinary meaning in the technical field. Unless otherwise expressly stated, all references to “a / an / the element, device, component, apparatus, etc.” shall be openly interpreted as referring to at least one instance of the element, device, component, apparatus, etc. Attached Figure Description

[0077] Specific embodiments of the inventive concept will now be described by way of example only with reference to the accompanying drawings, in which:

[0078] Figure 1 An example of the needle guide of the present invention is shown;

[0079] Figures 2 to 3 Another example of the needle guide of the present invention is shown;

[0080] Figures 4 to 5 It shows a sensor with connection. Figures 2 to 3 Needle guide;

[0081] Figures 6A to 6B It shows Figure 3 The order of use of the needle guide in the middle;

[0082] Figure 7 It shows Figure 3 Another order of use for the needle guide in the process;

[0083] Figure 8 Showing in use Figure 1 Needle guide;

[0084] Figures 9A to 9C It shows Figure 1 The order of use of the needle guide in the middle;

[0085] Figures 10A to 10B It shows the use with the tube. Figure 1 Needle guide;

[0086] Figure 11 It shows Figures 2 to 3 Another example of a needle-guided component. Detailed Implementation

[0087] The inventive concept will now be described more fully below with reference to the accompanying drawings, in which exemplary embodiments are illustrated. However, the inventive concept can be implemented in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Throughout the specification, the same reference numerals refer to the same elements.

[0088] Figures 1 to 11Examples include needle guides 1, 1', 1a, 1b, and 1c configured to provide a placement guide for a needle of a drug delivery device to a drug delivery site. Each needle guide includes a body 10, 10' configured to be removably attached to the drug delivery site. Needle seats 11, 11' are configured to be operatively connected to a needle of the drug delivery device. An electronic unit 12 is attached to the bodies 10, 10' of the needle guides 1, 1', 1a, 1b, and 1c. In a first aspect of the invention, the electronic unit 12 includes indicators 120, 120a, 120b, 120a', and 120b' configured to provide at least one of visual, auditory, and tactile indications to a user of the drug delivery device. Alternatively or additionally, in a second aspect of the invention, the electronic unit 12 includes a position detector configured to detect the position of another needle guide relative to the electronic unit, such that the two needle guides can be guided to be spaced apart from each other by a predetermined distance.

[0089] A first aspect of the invention is configured to provide an indication of proximity to the drug delivery site. Since large-volume and / or long-duration drug delivery devices are typically designed to be placed away from the drug delivery site, providing indications to the user may not be suitable. Furthermore, an indication of proximity to the drug delivery site can guide the user to easily place the needle.

[0090] The needle guide can be designed to physically guide the user to place multiple needles in predetermined locations. For example, a needle guide may have multiple needle holders spaced apart from each other. Alternatively, multiple needle guides can be used to form a grid to guide the placement of multiple needles. As defined in the second aspect of the invention, the electronic unit 12 includes a position detector configured to detect the position of another needle guide relative to the electronic unit. Thus, when multiple needle guides are used, data on the detected positions of the multiple needle guides can be used to virtually guide the user to place multiple needles. For example, the user can view a data-generated grid on a computer screen or telephone screen. Alternatively, in an example where the electronic unit includes an indicator as mentioned in the first aspect of the invention, an indication can be generated based on the detection from the position detector. Thus, the needle guide can be compact. In a preferred example, a needle guide is designed to attach to only one needle. It should be noted that such a design can obviously include both physical and virtual aspects. Furthermore, different combinations of physical and virtual implementation schemes can be implemented based on treatment, protocol, device architecture, and usage model.

[0091] It should be noted that the term "needle" as used herein refers to one of a right-angle needle, a straight needle, a soft cannula, or a soft cannula having an insertion needle configured to penetrate the user's skin. It should be noted that most insertion needles used with soft cannulas are removed after penetration; therefore, only the soft cannula remains in the user's body during the drug delivery procedure. It should be noted that right-angle needles and straight needles include hollow needle tubes configured to connect the drug to the drug delivery site of the drug delivery device. On the other hand, insertion needles do not necessarily include hollow needle tubes.

[0092] The bodies 10 and 10' of the needle guides 1, 1', 1a, 1b, and 1c can be circular, elliptical, or have another shape, such as a polygon. For example, as Figure 1 The main body 10 of the needle guide 1 shown is primarily circular. Alternatively, such as Figures 2 to 3 The body 10' of the needle guide 1' shown can be formed in different shapes. While other shapes for each guide are obviously possible, the size and shape of each needle guide 1, 1', 1a, 1b, 1c should preferably be shaped to give the user a negative cue about placing the guide in the wrong position. For example, placing an abdominal guide on top of the thigh may undesirably wrap around the groin or extend above the knee bend, both of which indicate to the user that this is not the correct application. Additionally, the needle guide 1' includes a placement reference point 14', for example, a through-hole indicating alignment with the knee.

[0093] In such Figure 1 and Figure 11 In one example shown, the needle is configured to be directly attached to the needle holder 11. For example, the needle can be attached to the needle holder via an adhesive layer. Alternatively, the needle can be attached to the needle holder via a hook-and-loop fastener. Using the hook-and-loop fastener, the needle can be removed from the needle guides 1, 1a, 1b, 1c after use. Therefore, the needle guides 1, 1a, 1b, 1c are suitable for reusability. Figure 1 In one example shown, the needle guide 1 is configured to attach to a needle of the drug delivery device. Alternatively, as... Figure 11 The needle guide 1 shown is configured to attach to a plurality of needles 2' of the drug delivery device 4. In this example, the plurality of needles 2' are connected to the drug delivery device via a plurality of tubes 20. In this example, the needle guide 1 includes a plurality of needle hubs 11. In a preferred example, the needle guide 1 includes a wearable feature 15 configured to be worn by a user, such as a strap, shoulder strap, tie, garment, leg warmer, or belt clip.

[0094] Alternatively, in such a location Figures 2 to 3In another example shown, the needle guide 1' is configured for use with a plurality of needles of a drug delivery device configured to be attached to a drug delivery site via an adhesive. For example, the plurality of needles are attached to the drug delivery site via medical tape. In this example, each of the plurality of needles is configured to be positioned adjacent to the needle hub 11'. Alternatively or additionally, the needles are pre-attached to, for example... Figure 2 The patch 3 is shown. In this example, it typically instructs the user to place the needle at the drug delivery site via the patch. In this example, medical tape or patch is attached to the needle hub 11', or at least partially contacts the needle hub 11'. In this example, the needle guide 1' includes a plurality of needle hubs configured to be operatively connected to each needle.

[0095] Electronic unit 12 is attached to the body of needle guides 1, 1', 1a, 1b, 1c. Electronic unit 12 may include a memory and / or a processor. Alternatively or additionally, electronic unit may include a communication unit configured to receive control signals from a computing device. Furthermore, electronic unit 12 is electrically connected to a power supply unit, such as a battery or energy harvesting unit. In one example where the needle guide is reusable, the electronics and power supply are selected such that their lifespan is approximately the same as the planned number of uses of the needle guide (optionally with a safety factor). In another example, the power supply may have a lower capacity but is recharged using motion-powered inductive charging. In this way, the battery can be recharged while the patient moves normally throughout the infusion. Furthermore, in another example, it may be desirable to reduce the manufacturing cost of the needle guides described in the above examples; in this example, electronic unit 12 is removably attached to needle guides 1, 1', 1a, 1b, 1c. For example, electronic unit 12 may be positioned at the center of the needle guide and connected to multiple indicators, and the electronic unit can be removed from the indicators and the needle guide for charging. In one example, the electronic unit is configured to be removed after the needle guide is attached to the drug delivery site and before the needle is attached to the needle guide. Alternatively, the electronic unit may be removed after drug administration or only when the electronic unit needs to be charged or the battery replaced.

[0096] In one example, the electronic unit has a dedicated charging unit. In another example, the electronic unit is configured to be stored on an interface on the drug delivery device. Optionally, this interface can additionally charge the electronic unit while the drug delivery device is charging. This is preferred for compressing reusable components for storage and reducing the risk of losing a component, especially when the electronic unit is small.

[0097] In a first aspect of the invention, indicators 120, 120a, 120b, 120a', and 120b' are configured to provide at least one of visual, auditory, and tactile indications to a user of the medication delivery device. In one example, indicators 120, 120a, 120b, 120a', and 120b' are configured to provide indications to guide the user to place the needle 2 onto the needle guide 1. For example, a user requiring different medications may use the same needle guide 1'. Since different medications may result in skin wheals of different sizes, the safe distance at which multiple skin wheals can be avoided from overlapping may also differ. Figure 6B In one example shown, the electronic unit 12 includes a first indicator 120a configured to provide indication in one color and a second indicator 120b configured to provide indication in another color. In this example, the first indicator 120a can be used to guide the user to place a needle connected to a first drug. In one example, the first drug is configured to be administered via two needles. In one example, the first drug is a small molecule drug; therefore, even if the two needles connected to the first drug are placed adjacent to each other, the skin wheal may not be noticeable. Therefore, as Figure 6B As shown, the first indicator 120a provides guidance (e.g., blue light) to the user for positioning the two needles connected to the first agent. Furthermore, in this example, the second indicator 120b is configured to guide the user to position the needle connected to the second agent. In this example, the second agent is a macromolecular agent. Therefore, as... Figure 6B As shown, the second indicator 120b provides another indicator (e.g., red light) to instruct the user to position the needle connected to the second agent away from the needle connected to the first agent.

[0098] Similarly, such as Figure 8In another example shown, a user can use multiple needle guides 1a, 1b, 1c to connect multiple needles respectively. In this example, at least one indicator from the multiple needle guides is configured to provide an indication different from the indications of other indicators from the other needle guides. In this example, the user can be guided to place multiple needles into different drug delivery sites in a specific order. For example, a user can use three needle guides 1a, 1b, 1c to place three needles into drug delivery sites. In one example, each of the three needles is connected to a different drug than the other needles. In this example, one indicator from the three needle guides 1a, 1b, 1c is configured to provide an indication in one color (e.g., blue); another indicator from the three needle guides 1a, 1b, 1c is configured to provide an indication in another color (e.g., green); and yet another indicator from the three needle guides 1a, 1b, 1c is configured to provide an indication in a color different from the other two indicators (e.g., red). In this example, preferably, the three needles also include matching colors, and the user can be instructed to connect each needle to one of the three needle guides, which has a color matching a specific needle with a corresponding color; for example, the green needle guide should be connected to a needle that includes green. Furthermore, the user can be instructed to connect the needles in sequence, such as blue, green, and red. In one example, the user is instructed to connect the next needle only when the medication from the needle has been administered. Therefore, the user can receive, for example, three different medications in a predetermined order.

[0099] In another preferred embodiment, the electronic unit 12 includes a communication unit configured to wirelessly communicate with another pin guide. Wireless communication can be based on any suitable technology, such as Bluetooth, Bluetooth Low Energy (BLE), radio frequency (RF), such as RFID, NFC, Zigbee, GPRS, WiFi, cellular, etc. In one example, a pin guide 1, 1a, 1b, 1c is configured to be attached to a pin. In one example, wireless communication between the electronic units 12 of the multiple pin guides can detect the distance between two pin guides. The distance can be detected based on the received signal strength of the electronic unit. Alternatively, the electronic unit 12 includes a proximity sensor configured to detect the position of another pin guide. In one example, when a user attaches a second pin guide 1b next to a first pin guide 1a, a warning indication, such as a red light or sound, can be provided by an indicator on the electronic unit 12 on the second pin guide 1b. When the user moves the second pin guide 1b sufficiently away from the first pin guide 1a, the indicator can provide an indication (e.g., a green light) to indicate that an appropriate position has been selected. Similarly, when the user attaches the third pin guide 1c, the indicator of the electronic unit of the third pin guide 1c is configured to provide an indication of whether the third pin guide 1c is too close to the first pin guide 1a or the second pin guide 1b.

[0100] It should be noted that the appropriate distance is predetermined based on the medication, patient population, and medication delivery device (e.g., medication delivery rate). Appropriate distances for different treatment regimens (e.g., combinations of multiple medications and / or one or more medications delivered at different rates) are pre-programmed in the electronic unit. Furthermore, it should be noted that the electronic unit 12 does not need to include an indicator unit as defined in the second aspect of the invention in order to detect the appropriate distance for placing the needle guide. In this example, the appropriate positions of multiple needle guides can be displayed on a computing device (e.g., a computer or smartphone) to provide a virtual grid to guide the user in placing the needle guides. For example, in this example, the user placing the needle guides could be a healthcare provider.

[0101] In a second aspect of the invention, the position detector includes a proximity sensor for detecting the position of another pin guide. In a preferred example, the position detector includes a communication unit. In this example, the processor is configured to calculate the position of the other pin guide relative to the electronic unit based on signals transmitted / received by the communication unit. The position of the other pin guide may be defined by the distance between the two pin guides.

[0102] In a preferred example, the electronic unit includes a processor. Alternatively, the processor may be located at a computing device (e.g., a cloud server) remote from the electronic unit containing the needle guides. In this example, transmit / receive signals are configured to be sent to the computing device, which calculates the position and sends control signals back to the electronic unit. Alternatively, in an example of generating a mesh of multiple needle guides and displaying it on a remote computing device, only the calculated distances may be maintained and displayed on the remote computing device, rather than being sent back to the electronic unit.

[0103] Furthermore, distance calculation can be based on the received signal strength, the angle of arrival of the received signal, and / or the departure angle of the emitted signal (e.g., an interrogation signal emitted by the communication unit of the electronic unit). Additionally, the distance between different needle guides can also be distinguished by a common identifier associated with each guide. In a preferred example, distance calculation is based on all received signal strengths, the angle of arrival of the received signal, and / or the departure angle of the emitted signal (e.g., an interrogation signal emitted by the communication unit of the electronic unit). This example is particularly advantageous for ensuring proper separation between devices because position detection can be more accurate when both distance and orientation are detected. Furthermore, all needle guides must be positioned on the skin for injection, such as... Figure 8 As illustrated in the illustration. Because the attachment area is inherently limited by the body (e.g., the thigh or abdomen), the distance between needle guides will be relatively small. Therefore, using only one method to detect the position of the needle guides may be insufficient to determine the distance, especially on a smaller scale. Additionally, a second aspect of the invention can optionally detect excessive distances between one or more electronic units, corresponding to one or more electronic units being completely away from the delivery site, which helps to identify missed injection site placements or electronic units that have not yet been placed.

[0104] For example, such as Figure 8 As shown, the initially placed needle guide g1 can then engage with subsequently placed needle guides g2, g3, as previously described. Needle guide g1 can be attached to the skin, while needle guides g2, g3 can move freely in this case (i.e., they are not attached to the skin), thereby changing their distances a, b, and c relative to each other. During this time, the communication unit is active on the engaging electronic units, which continuously calculate the relative spacing in response to movement. When the distances a, b, and c (or ∠AB, ∠AC, or ∠BC) are sufficiently far apart to allow the administration of three agents without overlapping subcutaneous reservoirs, an indication can be provided to the user, wherein the electronic units of needle guides g2, g3 illuminate, indicating that they can be attached to the skin at that location. In a preferred example, the communication unit is based on Bluetooth micro-positioning technology. In a preferred example, the position detector is configured to detect the position of one or more needle guides using the following steps:

[0105] • Analyze the received signal strength transmitted from the first pin guide to the second pin guide, optionally in conjunction with the pin guide identifier;

[0106] • The signal strength of the received signal transmitted from the first needle guide to one or more other needle guides, optionally including a needle guide identifier corresponding to the signal strength of the received signal, transmitted to other proximal and / or receiving needle guides;

[0107] • Detect the angle of arrival (AoA) of one or more incoming Bluetooth signals on the receiving needle guide, optionally incorporating a needle guide identifier associated with the incoming AoA measurement;

[0108] • Determine the departure angle (AoD) and / or transfer the departure angle (AoD) from the first needle guide to one or more other disks, optionally in conjunction with a needle guide identifier associated with the outgoing AoD, to other proximal or receiving needle guides;

[0109] • Transmit at least one data packet from a first needle guide to one or more other receiving needle guides, the at least one data packet having one or more of the following: needle guide identifier, angular relationship, distance, value corresponding to the order of use, total number of drugs within the dosing interval, or spacer size (diameter, large diameter, or small diameter, etc.) corresponding to the injection site size; and

[0110] • Optionally, based on the pin guide identifier, one or more pin guides may be prompted (e.g., prompted or questioned) to change the transmission power, polling frequency, announcement interval, or other Bluetooth parameters to further refine the positional aspect (i.e., angular or linear relationship) relative to the polling pin guide or one or more near-side or receiving pin guides.

[0111] Furthermore, in another example, electronic unit 12 includes a communication unit configured to wirelessly communicate with the drug delivery device. Similarly, the wireless communication unit is configured to transmit and / or receive signals, and the wireless communication can be based on any suitable technology, such as Bluetooth, Bluetooth Low Energy (BLE), radio frequency (RF), RFID, NFC, Zigbee, GPRS, WiFi, cellular, etc. Because large-volume and / or long-duration drug delivery devices are typically designed to be placed far from the drug delivery site, for example, 1-2 meters away, and are designed to be connected to one or more needles via a drug delivery tube, the user receiving the drug may have difficulty receiving instructions from the drug delivery device. Therefore, in one example where electronic unit 12 is configured to wirelessly communicate with the drug delivery device, an indicator can provide one or more indications to indicate the status of the drug delivery device, such as the start of the drug application operation, the end of the drug application operation, the progress of the drug application operation, and error messages. In this example, the needle guide receives information from the drug delivery device via the communication unit of electronic unit 12 to provide user instructions via the indicator. For example, Figure 6A A needle guide 1' is depicted, wherein the two needle holders 11' of the needle guide 1' have flashing lights as indicators 120a' to indicate and guide the user to place the needle accordingly.

[0112] In this example, the user can receive indications from needle guides 1, 1', 1a, 1b, and 1c. For example, the drug delivery device could be an infusion device suspended 1.5 meters above the drug delivery site; the user can receive indications, such as light and / or vibration from the needle guides on the thigh, rather than inspecting the infusion device. Figure 7 As shown, indicator 120a' indicates that a drug delivery operation is in progress from a needle attached via patch 3a” adjacent to the needle hub; and indicator 120b' indicates that a drug delivery operation is completed from a needle attached via patch 3b adjacent to the needle hub. For example, the illumination indicator can be additionally configured to provide feedback on the progress of a given drug administration. Figure 7 An indicator 120a' is depicted that is divided into progress bars along the spacer interface. Alternatively, a similar arc-shaped or circular lighting indicator can be used around the needle.

[0113] In a preferred example, the start indication can be signaled by a breathing-like dimming and brightening pattern or a small, repetitive movement of a loading icon. This can be particularly important because some drug delivery devices operate very quietly, and users may have difficulty distinguishing when they start and when they finish.

[0114] In another example, it might be desirable to use needle guides and indicators to communicate error status to the user and aid in troubleshooting. By positioning error feedback on the needle guide (as a supplement or alternative to positioning it on the drug delivery device), the user can be more clearly guided to the location of the error. Any error signals on the guide should be consistent in color and design with the signals used on the drive unit to avoid confusion.

[0115] In one example, an illumination indicator can be used to illuminate an additional color associated with the error state (e.g., a flashing red light). While many implementations of error states are possible, it is important that the error state illumination is clearly distinct from any state assigned during normal use. If the drug delivery device senses an error—for example, a blocked fluid path, a kinked cannula, or an unintentionally removed needle during administration, as sensed by one or more built-in sensors of the drug delivery device—the relevant information is transmitted to the electronics of the needle guide, thereby illuminating one or more affected sites in this way. Helping the user identify which site requires troubleshooting (e.g., reinsertion, replacement, etc. as needed) is particularly useful for errors such as cannula kinking or blockage that may not be visually apparent to the user. In some use cases, it may be necessary to alert the user to the error state in an urgent or other timely manner. The indicator may additionally include one or more tactile feedback elements, such as an eccentric rotating mass vibrating motor. These tactile elements can be used alone or in combination with other error signaling methods to alert the user to the presence of an error state.

[0116] In another implementation, individual lighting elements on the guide can be used to indicate the location and nature of the error state. For example, a needle guide with an illuminated indicator can be located beneath the top layer of the needle guide, making the indicator invisible when not illuminated. Each hidden illuminated indicator can take the form of a symbol or character when illuminated. Similar to a car dashboard light, when a specific error state is detected, the drug delivery device will convey information to the needle guide to illuminate a hidden symbol corresponding to the relevant error state.

[0117] The indications provided by the electronic unit 12 of the needle guide described in this disclosure can be used alone or in conjunction with indications on the drug delivery device. For several reasons, it is desirable to position some indications on the user's body. The needle guide can provide indications of the position or incorrect position of a given step, helping the user understand what the correct subsequent action is. This is particularly advantageous for steps or actions located closer to the proximal end of the device, including but not limited to needle guide placement steps, needle insertion steps, tubing connection steps, and corresponding removal steps, whereas indications on the drug delivery device need to be removed from the step or incorrect position and require additional understanding from the user. Furthermore, positioning the indications on the user's body is attractive because the user can cover the indications with clothing for judgment while still being able to check them as needed.

[0118] In a preferred example, the needle guide includes a self-contained power unit, such as a battery or energy harvesting unit, and communicates wirelessly with the drug delivery device. This is advantageous because it allows the user to be alerted before the fluid path for drug delivery is completed within the user's scheduled workflow. Additionally, an alert can be provided if the fluid path is unexpectedly interrupted during wear.

[0119] In one example, electronic unit 12 includes a communication unit configured to wirelessly communicate with the medication delivery device and another needle guide. Alternatively, electronic unit 12 includes two separate communication units configured to wirelessly communicate with the medication delivery device and another needle guide, respectively. For example, the communication unit could be an NFC-based communication unit configured to communicate with the other needle guide; and the communication unit could communicate with the medication delivery device based on Bluetooth technology. It should be noted that the communication unit of the electronic unit can be used to communicate with one or more computing devices (e.g., mobile phones, cloud, computers); alternatively, the electronic unit may include multiple communication units based on the same or different telecommunications technologies to communicate with one or more computing devices and the medication delivery device / another needle guide, respectively. Furthermore, in a preferred example, a mesh network can be created among the multiple needle guides. Additionally, the communication units are configured to transmit a unique ID (UID) to the mesh network, allowing each needle guide to identify itself within the mesh network. In this example, an instruction can be provided to the user if a predetermined number of needle guides are not fully attached to the user's skin. For example, the electronic or computational process is repeated for any subsequent needle guides until the mesh network determines that no additional needle guides have been added to the network within a threshold or timeout period. The number of needle guides corresponds to the number of needles the system expects to attach at the end of drug administration. All sites are located and ready for drug administration, and all sites are covered before use.

[0120] The body 10' of the needle guide 1' includes a plurality of needle hubs 11' configured to be operatively connected to a plurality of needles of a drug delivery device. The electronic unit 12 includes a plurality of indicators 120, 120a, 120b, 120a', 120b', such as... Figure 3 , Figures 6A to 7 As shown. In a preferred example, multiple indicators 120, 120a, 120b, 120a', and 120b' are respectively positioned next to multiple needle seats 11'. In a preferred example, at least one of the multiple indicators 120a is configured to provide an indication different from the other multiple indicators 120b, such that the multiple indicators 120a and 120b are configured to indicate to the user the placement order of the multiple needles of the drug delivery device, such as... Figures 6A to 6B As shown.

[0121] In another example, the bodies 10 and 10' of the needle guides 1, 1', 1a, 1b, and 1c include a tube seat configured to attach to a tube 20 of the drug delivery device, which connects the needle 2 and the drug container of the drug delivery device. The tube 20 may be pre-attached to the needle or may be attached to the needle by the user of the drug delivery device. In an example where the needle includes a flexible cannula, the tube 20 may be an integral part of the flexible cannula. In a preferred example, an indicator may be located near the tube seat. In this example, the indicator may be used to interact with the tube 20 to provide guidance to the user. For example, the indicator may project an image onto the tube or emit light onto the tube. In an example where the indicator emits light onto the tube, the user may see different light patterns, such as different colors, different brightness, and / or different reflections 201, when the tube contains different volumes of drug. Figures 10A to 10B As shown. Therefore, the user is informed of the progress and end of the drug administration procedure.

[0122] Furthermore, in another example, needle guides 1, 1', 1a, 1b, and 1c can be used with a patch 3' including electronics. In this example, the needle 2 is configured to attach to a drug delivery site via the patch 3'. In one example, indicators 120, 120' of the electronics 12 are operatively connected to the needle. For example, as... Figure 5 As shown, patch 3' includes a connection port 31" and an indicator 32'. The connection port 31" is electrically connected, for example, via wire 121' to the electronic units 12, 12' of the needle guide. In this example, the indicator of the needle guide can provide indication to the user on the needle guide and / or on the indicator 32' of patch 3'.

[0123] Furthermore, in another preferred embodiment, the electronic unit includes a connection sensor configured to detect operatively mounted needles to a needle holder of a needle guide. The connection sensor may be a mechanical switch, a reed switch, an optical switch, or a circuit configured to be activated by contact between needles 2, 2 and needle holders 11, 11'. In an example where the connection sensor is a mechanical switch, needles 2, 2' and / or patches 3, 3' are configured to press the mechanical switch when attached to needle holders 11, 11'. In one example, needles 2, 2' may include a magnetic element, and the contact sensor includes a reed switch. In an example where the switch is a circuit configured to be activated by contact between needles 2 and needle holders 11', needles 2 and / or patches 3' may include a conductive surface 31' configured to contact a reverse conductive surface 121 of needle holder 11', such as... Figure 4 As shown. In one example where the sensor is an optical switch, pins 2, 2' and / or patches 3, 3' are configured to cover the optical switch when pins 2, 2' are attached to the pin guide.

[0124] Optionally, the patches 3, 3' configured to attach the needle to the user's skin can be specifically modified to indicate accidental needle removal. In this usage scenario, the force required to disconnect the circuit element is approximately equal to the force required to begin removing the needle (if not completely removed from the skin) and less than the force required to remove the adhesive from the patches 3, 3'. An indicator (e.g., an illumination element) on the needle guide is configured such that it is always on when the connection between the needle guide and the patches 3, 3' is complete. Accidental needle removal disconnects the circuit, and the indicator (e.g., the illumination element) turns off. This indicates to the user that the element should be on during normal use, and that if the element is off, there is a problem where the needle may not be visible.

[0125] Preferably, in one example where the electronic unit 12 of the needle guide includes a communication unit configured to communicate wirelessly with another needle guide, the communication unit is configured to send a signal to the other needle guide in response to detection by a connection sensor of the needle guide, such that an indicator of the other needle guide provides an indication in response to the signal.

[0126] Furthermore, as mentioned above, multiple needle guides can be used to guide the user to place multiple needles in a specific order. For example, such as... Figures 9A to 9CAs shown, three needle guides 1a, 1b, and 1c can be used to guide the user to place three needles respectively. In this example, the user can first place the three needle guides 1a, 1b, and 1c onto the skin. The distance / position detection in this example can be calculated as mentioned above and disclosed in the second aspect of the invention. The communication unit of the electronic unit of each needle guide is configured to communicate with the other needle guide, such that all needle guides are placed at a predetermined distance from each other, for example, the distance is detected based on the received signal strength of the electronic unit or detection from a proximity sensor, and an indication is provided by an indicator to indicate the appropriate position to the user and guide the user to place the needle guide accordingly, as mentioned above. Alternatively or additionally, the distance between the needle guides can be detected based on one or more of the angle of arrival of the signal, the angle of departure of the signal, or the received signal strength. The distance between different needle guides can also be distinguished by a common identifier associated with each guide. The user then places each needle onto each needle guide respectively. In one example, where a user is instructed to place a needle connected to a first type of medication into the medication delivery site, and then, after delivering the first type of medication to the injection site, place another needle connected to a second type of medication into the medication delivery site, the communication unit of the electronics 12 of the needle guide 1a connected to the needle connected to the first type of medication is configured to send a signal to the other needle guide 1b (e.g., the needle guide connected to the needle connected to the second type of medication) in response to detection by the connection sensor of the needle guide 1a. Therefore, the indicator 120 of the other needle guide 1b can provide an indication in response to this signal, indicating when the user should place the needle connected to the second type of medication into the medication delivery site. For example, predetermined medication delivery time information can be pre-programmed into the electronics of the needle guide 1a connected to the needle connected to the first type of medication or the needle guide 1b connected to the needle connected to the second type of medication. Thus, once the predetermined medication delivery time information expires, a signal can be sent and / or an indication can be provided. Figures 9A to 9C As shown, indicators 120a, 120b, and 120c are configured to provide instructions to the user in a predetermined order to guide the user to place the needle at the drug delivery site in this order.

[0127] In another example, the electronic unit 12 includes a skin sensor configured to detect that the bodies 10, 10' of the needle guides 1, 1', 1a, 1b, 1c are attached to the drug delivery site.

[0128] Furthermore, in one example, at least a portion of the circuitry of the electronic unit is made of conductive ink. In this example, the cost of the needle guide can be reduced.

[0129] The injection components described herein can be used to treat and / or prevent one or more of many different types of diseases. Exemplary diseases include, but are not limited to: rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia, diabetes (e.g., type 2 diabetes), psoriasis, migraine, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylactic reactions, and allergic reactions. Exemplary drug types that may be included in the drug delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptides, polypeptides, PEGylated proteins, protein fragments, protein analogs, protein variants, protein precursors, chimeric antigen receptor T-cell therapy, cell or gene therapy, oncolytic viruses, or immunotherapy. Exemplary drugs that may be included in the injectable components described herein include, but are not limited to (non-limiting examples of related diseases in parentheses): etanercept (rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type 2 diabetes), secukinumab (psoriasis), eleneumab (migraine), alicurumab (rheumatoid arthritis), and folate (methotrexate) (rheumatoid arthritis). Rheumatoid arthritis), tocilizumab (for rheumatoid arthritis), interferon beta-1a (for multiple sclerosis), sumatriptan (for migraine), adalimumab (for rheumatoid arthritis), dapoxetine alpha (for anemia), belimumab (for lupus), pegylated interferon beta-1a' (for multiple sclerosis), thalidomide (for rheumatoid arthritis), semaglutide (for type 2 diabetes and obesity), dupilumab (for atopic dermatitis, asthma, nasal polyps, and allergic reactions). Glucagon (acute hypoglycemia), adrenaline (allergic reactions), insulin (diabetes), atropine and vedocillin (inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), immunoglobulins (primary immunodeficiency), ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cimiprimab, rituximab, trastuzumab, adortrastuzumab, detrastuzumab, pertuzumab, trast ... Tocilizumab - Pertuzumab, Alenzabumab, Mabelantuzumab, Bevacizumab, Bonatumab, Vebutuximab, Cetuximab, Daremumab, Ilotuzumab, Gefituzumab, Ozolmicin, Yttrium 90, Izatoximab, Moglitoximab, Mosetuzumab, Obitutuzumab, Ofatuzumab, Olatuzumab, Panitumab, Polotuzumab, Ramucirumab, Gosatoximab, Tancitoximab, or Magutuzumab.Pharmaceutical formulations, including but not limited to any of the drugs described herein, are also contemplated for use in the pharmaceutical delivery devices described herein, such as pharmaceutical formulations comprising the drugs listed herein (or pharmaceutically acceptable salts of drugs) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising the drugs listed herein (or pharmaceutically acceptable salts of drugs) may include one or more other active ingredients, or may be the only active ingredient present. Pharmaceutical formulations may also include dispersion enhancers, such as hyaluronidase, administered alone or co-formulated.

[0130] Exemplary drugs that may be included in the drug delivery device described herein include, but are not limited to, immuno-oncology or biological oncology agents, such as immune checkpoints, cytokines, chemokines, differentiation clusters, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or co-stimulatory proteins.

[0131] Exemplary drugs that may be included in the drug delivery device described herein include, but are not limited to, those exhibiting the proposed mechanisms of action, such as HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD-1 / PD-L1 inhibitors / modulators, B lymphocyte antigen CD19 inhibitors, B lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, TIM-3 modulators, VISTA modulators, INDO inhibitors, etc. Formulations, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B lymphocyte cell adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1OX40 receptor agonist modulators, adenosine A2 receptor modulators, ICOS modulators, CD40 modulators, TIL therapy or TCR therapy.

[0132] Exemplary drugs that may be included in the drug delivery device described herein include, but are not limited to, multi-drug therapy regimens such as AC, dose-dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, dose-dense CHOP, EPOCH, dose-adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7+3, 5+ 2, 7+ 4. MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VeIP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC or PE.

[0133] Exemplary drugs that may be included in the drug delivery device described herein include, but are not limited to, those used for chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites or topoisomerase inhibitors, enzymes, retinoids or corticosteroids. Exemplary chemotherapy drugs include, for example but not limited to, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dazometazidine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, phenylalanine mustard, methotrexate, pemetrexed, mitomycin, mitoxantrone, tesiromoxim, topotecan, pentorubicin, vincristine, vinblastine, or vinorelbine.

[0134] The foregoing description primarily refers to several examples to illustrate the inventive concept. However, as will be readily understood by those skilled in the art, other embodiments besides those disclosed above may also be within the scope of the inventive concept as defined in the appended claims.

[0135] Other aspects of the invention are defined by the following provisions.

[0136] 1. A needle guide (1; 1'; 1a, 1b, 1c) configured to provide a placement guide for a needle of a drug delivery device to a drug delivery site, the needle guide comprising:

[0137] A body (10; 10') configured to be removably attached to the drug delivery site;

[0138] A needle hub (11; 11') configured to be operatively connected to the needle of the drug delivery device;

[0139] An electronic unit (12) is attached to the body (10; 10') of the needle guide (1; 1'; 1a, 1b, 1c); and

[0140] The electronic unit (12) includes a position detector configured to detect the position of another needle guide relative to the electronic unit, such that the two needle guides can be guided to be spaced apart from each other by a predetermined distance.

[0141] 2. The pin guide according to Clause 1, wherein the electronic unit includes a communication unit configured to communicate wirelessly with another pin guide.

[0142] 3. The needle guide according to Clause 2, wherein the position detector includes the communication unit; and wherein the electronic unit includes a processor configured to calculate the position of the other needle guide relative to the electronic unit based on signals transmitted / received by the communication unit.

[0143] 4. The pin guide as described in Clause 3, wherein the calculated position is based on one or more of the following: received signal strength, received signal angle of arrival, departure angle of the signal transmitted by the communication unit, or a unique pin guide identifier for transmission and / or reception.

[0144] 5. The needle guide according to any one of the preceding clauses, wherein the position detector includes a proximity sensor configured to detect the position of another needle guide.

[0145] 6. The needle guide according to any one of the preceding clauses, wherein the electronic unit is removably attached to the body of the needle guide.

[0146] 7. The needle guide according to any one of the preceding clauses, wherein the electronic unit includes an indicator (120) configured to provide at least one of visual, auditory and tactile indications to a user of the drug delivery device.

[0147] 8. The needle guide according to any one of the preceding clauses, wherein the electronic unit includes a communication unit configured to communicate wirelessly with the drug delivery device.

[0148] 9. The needle guide according to a combination of Clauses 7 and 8, wherein the indicator is configured to provide an indication of the status of the drug delivery device.

[0149] 10. The needle guide according to any one of the preceding clauses, wherein the body of the needle guide includes a tube seat configured to be attached to a tube of the drug delivery device, the tube connecting the needle and the drug container of the drug delivery device.

[0150] 11. The needle guide according to any one of the preceding clauses, wherein the electronic unit includes a connection sensor configured to detect that the needle is operatively mounted to the needle hub of the needle guide.

[0151] 12. A needle guide according to Clause 11 when subordinate to Clause 7, wherein the communication unit is configured to send a signal to another needle guide in response to detection by the connection sensor of the needle guide, such that the indicator of the other needle guide provides an indication in response to the signal.

[0152] 13. A needle guide pursuant to Clause 7 or any of the preceding clauses when subordinate to Clause 7, wherein the indicator is configured to provide indication in response to the position of another needle guide.

[0153] 14. The needle guide according to any one of the preceding clauses, wherein the electronic unit includes a skin sensor configured to detect that the body of the needle guide is attached to the drug delivery site.

[0154] 15. The needle guide according to any one of the preceding clauses, wherein the electronic unit is configured to transmit the detected position to a remote computing device, such that a grid for the positions of a plurality of needle guides can be formed in the remote computing device.

Claims

1. A needle guide (1; 1'; 1a, 1b, 1c) configured to provide a placement guide for a needle of a drug delivery device to a drug delivery site, the needle guide comprising: A body (10; 10') configured to be removably attached to the drug delivery site; A needle hub (11; 11') configured to be operatively connected to the needle of the drug delivery device; Electronic unit (12), the electronic unit being attached to the body (10; 10') of the needle guide (1; 1'; 1a, 1b, 1c); The electronic unit (12) includes an indicator (120) configured to provide at least one of visual, auditory and tactile indications to a user of the drug delivery device to indicate information related to the placement of the needle and / or the position of the needle guide and / or the operation of the drug delivery device.

2. The needle guide of claim 1, wherein the electronic unit is removably attached to the body of the needle guide.

3. The needle guide according to claim 1 or 2, wherein the electronic unit includes a communication unit configured to communicate wirelessly with another needle guide.

4. The needle guide according to claim 3, wherein the other needle guide comprises: A body, the body being configured to be removably attached to the drug delivery site; A needle hub, configured to be operatively connected to the needle of the drug delivery device; An electronic unit is attached to the body of the needle guide; wherein the electronic unit includes an indicator configured to provide a user of the drug delivery device with at least one of visual, auditory, and tactile indications to indicate to the user information related to the placement of the needle and / or the position of the needle guide and / or the operation of the drug delivery device.

5. The needle guide according to any one of the preceding claims, wherein the electronic unit includes a communication unit configured to communicate wirelessly with the drug delivery device.

6. The needle guide of claim 5, wherein the indicator is configured to provide an indication of the status of the drug delivery device.

7. The needle guide according to any one of the preceding claims, wherein the body of the needle guide includes a plurality of needle hubs configured to be operatively connected to a plurality of needles of the drug delivery device; wherein the electronic unit includes a plurality of indicators; and wherein the plurality of indicators are respectively positioned next to the plurality of needle hubs.

8. The needle guide of claim 7, wherein at least one of the plurality of indicators is configured to provide an indication different from the other plurality of indicators, such that the plurality of indicators are configured to indicate to the user the placement order of the plurality of needles of the drug delivery device.

9. The needle guide according to any one of the preceding claims, wherein the body of the needle guide includes a tube seat configured to be attached to a tube of the drug delivery device, the tube connecting the needle and the drug container of the drug delivery device.

10. The needle guide according to any one of the preceding claims, wherein the electronic unit includes a connection sensor configured to detect that the needle is operatively mounted to the needle hub of the needle guide.

11. The needle guide according to claim 10 when dependent on claim 3 or 4, wherein the communication unit is configured to send a signal to another needle guide in response to detection by the connection sensor of the needle guide, such that the indicator of the other needle guide provides an indication in response to the signal.

12. The needle guide according to any one of the preceding claims, wherein the electronic unit includes a skin sensor configured to detect that the body of the needle guide is attached to the drug delivery site.

13. The needle guide according to any one of the preceding claims, wherein the electronic unit includes a proximity sensor configured to detect the position of another needle guide.

14. The needle guide of claim 13, wherein the other needle guide comprises: A body, the body being configured to be removably attached to the drug delivery site; A needle hub, configured to be operatively connected to the needle of the drug delivery device; An electronic unit is attached to the body of the needle guide; wherein the electronic unit includes an indicator configured to provide a user of the drug delivery device with at least one of visual, auditory, and tactile indications to indicate to the user information related to the placement of the needle and / or the position of the needle guide and / or the operation of the drug delivery device.

15. The needle guide according to claim 3 or 4, or any one of claims 5 to 15 when dependent on claim 3 or 4, wherein the electronic unit includes a processor configured to calculate the position to another needle guide based on signals transmitted / received by the communication unit.

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