Needle connectors and modular needle connectors for multi-dose drug delivery devices and use thereof

Abstract

To provide improved methods, devices, and systems to provide multi-dose injection regimens without risking contamination of a therapeutic agent disposed within a reusable injector.SOLUTION: Systems and devices include multi-dose injection systems for delivering drugs, hormones, biologics, and other therapeutic agents. The systems include multiple single-injection needle connectors 102 attachable to a reusable injector. The needle connectors include a needle 104 having a distal end 106 for administering a therapeutic agent to a patient and a proximal end 108 to pierce a septum of the reusable injector. Proximal ends of the needles across the multiple needle connectors can be varied such that a piercing location on the septum varies.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 63 / 011,029, filed April 16, 2020, and U.S. Provisional Patent Application No. 63 / 073,158, filed September 1, 2020, the entire contents of which are incorporated by reference herein as if fully set forth below.

[0002] The present invention relates generally to a multi-dose injection system for delivering drugs, hormones, biologics, and other therapeutic agents, and more particularly to a needle connector having various proximal needle positions corresponding to various piercing positions on a septum of a reusable injector. [Background technology]

[0003] There are many medical conditions that require regular injections to treat, alleviate, or prevent the underlying symptoms of the condition. Consider, for example, a diabetic patient who requires regular administration of insulin, or a patient with a thyroid disorder who requires daily injections of hormones. One thing that all regular, multi-dose injection regimens have in common is that if the administration of the drug, hormone, biologic, or other therapeutic agent is discontinued, significant problems can occur for the patient. This may include discomfort, pain, recurrence of the condition, or even death in some cases.

[0004] One current method of providing a multiple dose periodic injection regimen is to provide a reusable injector containing a therapeutic agent. A single injector can be reused for several injection regimens (e.g., hourly, weekly, biweekly, etc.). To ensure a sterile injection device, the injection system can include multiple disposable needle connectors that fit onto the tip of the reusable injector. The system can include a number of needle connectors corresponding to the number of injections provided by the reusable injector (e.g., 14 needle connectors for a 14 day injection regimen).

[0005] The needle connector may include a needle having a proximal end and a distal end, the distal end may be inserted into a patient, for example subcutaneously, to administer a therapeutic agent, and the proximal end may be inserted into a reusable injector where the tip of the proximal end pierces a septum to access a therapeutic agent stored within the injector.

[0006] Problems exist with existing injection systems as they relate to the way the septum of a reusable injector is pierced. All previous needle connectors pierce the same location on the septum. If many needle connectors are expected to be used with the same reusable injector (e.g., 14 needles for a 14-day regimen), the piercing and re-piercing of the septum can cause damage to the septum. This damage can lead to the generation of rubber particles that can fall into the therapeutic agent in the reusable injector. This can cause contamination of the therapeutic agent and potentially adversely affect the patient.

[0007] Therefore, there is a need for improved methods, devices, and systems for providing multi-dose injection regimens without exposing the therapeutic agent disposed within the reusable injector to the risk of contamination. Summary of the Invention

[0008] It is an object of the present invention to provide a system, device, and method that meets the above-mentioned needs. In general, it is an object of the present invention to provide an injection system with a needle connector having a variety of proximal needle positions that correspond to a variety of piercing positions on a septum of a reusable injector.

[0009] Exemplary systems described herein may include a reusable injector having a septum. The system may include a plurality of attachable needle connectors dimensioned to attach to a distal end of the reusable injector proximate the septum. The plurality of attachable needle connectors may include a first needle connector having a first needle. A proximal end of the first needle may correspond to a first location on the septum. The plurality of attachable needle connectors may include a second needle connector having a second needle. A proximal end of the second needle may correspond to a second location on the septum. The first location and the second location are different locations such that the septum may be pierced at different locations by the first needle connector and the second needle connector.

[0010] The system may include a first set of needle connectors. The first set may include a first needle connector and a third needle connector having a third needle. A proximal end of the third needle may correspond to a first location on the septum, similar to the first needle connector.

[0011] The distal end of the reusable injector may have a circular cross-section. The proximal end of each of the plurality of attachable needle connectors may be concentrically positionable in the distal end of the reusable injector. The proximal end of the first needle may be concentrically positioned in the distal end of the reusable injector. The proximal end of the second needle may be non-concentrically positioned in the distal end of the reusable injector.

[0012] The distal end of the reusable injector may include a first anti-rotation feature, and each of the plurality of attachable needle connectors may include a second anti-rotation feature dimensioned to engage the first anti-rotation feature.

[0013] The distal end of the reusable injector may have a circular cross-section. A proximal end of each of the plurality of attachable needle connectors may be concentrically positionable on the distal end of the reusable injector. The proximal end of the first needle may be offset from the second anti-rotation feature by a first radial offset. The proximal end of the second needle may be offset from the second anti-rotation feature by a second radial offset. The first radial offset may be different from the second radial offset such that the septum may be pierced at different locations by the first and second needle connectors.

[0014] The first anti-rotation feature may be one of a keyway or a key, and the second anti-rotation feature may be one of a key or a keyway and is the opposite of the first anti-rotation feature.

[0015] The first anti-rotation feature can be a first cross-sectional geometry at a distal end of the reusable injector. The second anti-rotation feature can be a second cross-sectional geometry at a proximal end of each of the plurality of attachable needle connectors. The first cross-sectional geometry and the second cross-sectional geometry can be non-circular to prevent rotation between the features.

[0016] The second needle may have a curved portion disposed between a proximal end of the second needle and a distal end of the second needle.

[0017] An exemplary kit may include a plurality of needle connectors attachable to a reusable injector. The kit may include a first set of one or more needle connectors, each of the needle connectors including a first needle. A proximal end of each first needle may be positioned to pierce a first location on a septum of the reusable injector. The kit may include a second set of one or more needle connectors, each of the needle connectors including a second needle. A proximal end of each second needle may be positioned to pierce a second location on the septum. The first location and the second location are different locations such that the septum may be pierced at different locations by the first set and the second set.

[0018] The first set and / or the second set can include between 2 and 5 needle connectors. In some examples, the first set and / or the second set can be limited to 5 needle connectors or less.

[0019] The first set may include a first needle connector and a second needle connector. The first needle connector may be indexed for a first injection regimen and the second needle connector may be indexed for a second injection regimen. The second set may include a third needle connector and a fourth needle connector. The third needle connector may be indexed for a third injection regimen and the fourth needle connector may be indexed for a fourth injection regimen.

[0020] The first set may include the first needle connector and the second set may include the second needle connector. The kit may further include a third needle connector, a fourth needle connector, a fifth needle connector, a sixth needle connector, and a seventh needle connector. Each needle connector may be indexed for one of the seven dose injection regimens. The proximal end of each needle connector may be positioned to pierce a different location on the septum.

[0021] Each needle connector of the first set may include a first anti-rotation feature dimensioned to correspond to a second anti-rotation feature of the reusable injector. Each needle connector of the second set may include a third anti-rotation feature dimensioned to correspond to the second anti-rotation feature of the reusable injector.

[0022] The first anti-rotation feature and the third anti-rotation feature may be one of a keyway or a key, and the second anti-rotation feature may be one of a key or a keyway and is the opposite of the first anti-rotation feature and the third anti-rotation feature.

[0023] The first and third anti-rotation features can be a first cross-sectional geometry of the proximal end of each of the first and second sets of needle connectors. The second anti-rotation feature can be a second cross-sectional geometry of the distal end of the reusable injector. The first and second cross-sectional geometries can be non-circular.

[0024] An exemplary method may include selecting a first needle connector for a first injection regimen. The first needle connector may be disposed proximate a distal end of a reusable injector. A septum of the reusable injector may be pierced at a first location by a proximal end of a first needle of the first needle connector. The first injection regimen may then be administered to the patient. A second needle connector may be selected for a second injection regimen. The second needle connector may be disposed proximate a distal end of the reusable injector. A septum of the reusable injector may be pierced at a second location by a proximal end of a second needle of the second needle connector. The second injection regimen may then be administered to the patient. The first and second locations may be different locations on the septum and / or the corresponding needle connector.

[0025] The method may include rotating the first needle connector to mate a first anti-rotation feature on the first needle connector with a second anti-rotation feature on the reusable injector.

[0026] The method may include selecting a third needle connector for a third injection regimen. The third needle connector may be disposed proximate to a distal end of the reusable injector. The septum may be pierced at a first location on the septum by a proximal end of a third needle of the third needle connector. The third injection regimen may then be administered to the patient.

[0027] An exemplary modular needle connector may include a circular disk having a needle opening disposed non-concentrically with a center of the circular disk. The modular needle connector may include a needle disposed within the needle opening. The needle may have a distal end extending from a first side of the circular disk and a proximal end extending from a second side of the circular disk. The modular needle connector may further include a connector body. The connector body may include a disk slot disposed at a first end of the connector body, the disk slot being dimensioned to receive the circular disk. The connector body may include an injector housing disposed at a second end of the connector body, the injector housing being dimensioned to engage a reusable injector. A proximal end of the needle may be disposed within the injector housing when the connector body engages the reusable injector.

[0028] The first height and the first diameter of the circular disk can be smaller than the second height and the second diameter of the disk slot such that the circular disk is rotatable within the disk slot when the connector body is disengaged from the reusable injector.

[0029] The connector body may include a plurality of flexible wings extending along at least a portion of the length of the injector housing. An inner surface of the plurality of flexible wings may include threads dimensioned to engage the reusable injector.

[0030] The distal end of the needle may include a beveled tip and the proximal end of the needle may include a non-coring tip, which may include a blunt tip and a lateral fluid inlet.

[0031] A system according to the present disclosure may include a reusable injector including a septum. The system may further include a modular needle connector. The modular needle connector may include a rotating disk including a needle extending through the rotating disk at a position not concentric with a center of the rotating disk. The needle may include a distal end extending from a first side of the rotating disk and a proximal end extending from a second side of the rotating disk. The modular needle connector may include a connector body. The connector body may include a disk slot disposed at a first end of the connector body, dimensioned to receive the rotating disk. The connector body may include an injector housing disposed at a second end of the connector body, dimensioned to engage a reusable injector. A proximal end of the needle may extend into the injector housing and may be movable from a first position within the injector housing to a second position within the injector housing by rotation of the rotating disk.

[0032] The connector body can include a plurality of flexible wings dimensioned to engage with the reusable injector adjacent the septum, and an inner surface of the plurality of flexible wings can include first threads dimensioned to engage with second threads of the reusable injector adjacent the septum.

[0033] The inner surface of the injector housing can include a first thread dimensioned to engage a second thread on the reusable injector adjacent the septum. The distal end of the needle can include a beveled tip and the proximal end of the needle can include a non-coring tip. The non-coring tip can include a blunt tip and a lateral fluid inlet.

[0034] The first axis of the rotating disk can be coaxial with the second axis of the septum. The needle can be off-axis from the first axis and the second axis.

[0035] The proximal end of the needle may be fixed when inserted into the septum, and the rotating disk may be fixed when the connector body is seated in the reusable injector.

[0036] The method may include disposing the modular needle connector proximate a distal end of the injector. The method may include piercing a septum of the injector at a first location with a proximal end of a needle in the modular needle connector. The needle may be connected to a rotating disk in the modular needle connector. The method may include axially advancing the modular needle connector to the distal end of the injector. The method may include rotating a connector body of the modular needle connector to disengage first threads of the connector body from second threads of the distal end of the injector. Rotating the connector body may rotate the rotating disk as the proximal end of the needle is axially withdrawn from the first location. The method may include removing the modular needle connector from the distal end of the injector.

[0037] The method may include piercing the septum at a second location with the proximal end of the needle. The method may include rotating the connector body to disengage the first threads from the second threads on the distal end of the injector. Rotating the connector body may rotate the rotating disk as the proximal end of the needle is axially withdrawn from the second location.

[0038] The needles may be positioned non-concentrically with respect to the center of the rotating disk.

[0039] Axial advancing the modular needle connector into the distal end of the injector can include advancing a flexible wing over the distal end of the injector. The first thread can be disposed on an inner surface of the flexible wing.

[0040] The method can include administering an injection regimen through the distal end of the needle.

[0041] The above and further aspects of the present invention are further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals in the various figures indicate like structural elements and features. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. The drawings illustrate one or more embodiments of devices of the present invention by way of example, and not by way of limitation. [Brief description of the drawings]

[0042] [Figure 1] FIG. 1 is a side view of a needle connector assembly according to an aspect of the present disclosure. [Figure 2A] FIG. 1 is a side view of a needle connector according to an aspect of the present disclosure. [Figure 2B] FIG. 1 is a side view of a needle connector according to an aspect of the present disclosure. [Figure 2C] FIG. 1 is a side view of a needle connector according to an aspect of the present disclosure. [Figure 3A] 1 is a perspective view of a needle connector and a corresponding reusable injector according to an aspect of the present disclosure. FIG. [Figure 3B] 1 is a perspective view of a needle connector and a corresponding reusable injector according to an aspect of the present disclosure. FIG. [Figure 4A] 1A-1C are side views of an exemplary method of mounting a needle connector to a reusable injector, according to aspects of the present disclosure. [Figure 4B] 1A-1C are side views of an exemplary method of mounting a needle connector to a reusable injector, according to aspects of the present disclosure. [Figure 4C] 1A-1C are side views of an exemplary method of mounting a needle connector to a reusable injector, according to aspects of the present disclosure. [Figure 5A] 1A-1C are end views of an exemplary needle arrangement of a needle connector according to aspects of the present disclosure. [Figure 5B]1A-1C are end views of an exemplary needle arrangement of a needle connector according to aspects of the present disclosure. [Figure 6A] 1 illustrates another exemplary needle arrangement of a needle connector according to aspects of the present disclosure. [Figure 6B] 1 illustrates another exemplary needle arrangement of a needle connector according to aspects of the present disclosure. [Figure 7] 13 illustrates yet another example of a needle placement pattern according to aspects of the present disclosure. [Figure 8] 13 illustrates yet another example of a needle placement pattern according to aspects of the present disclosure. [Figure 9] 1 illustrates an example of a needle placement pattern with an anti-rotation feature, according to aspects of the present disclosure. [Figure 10] 13 illustrates an example needle placement pattern with another example anti-rotation feature, according to aspects of the present disclosure. [Figure 11] 13A-13C illustrate example needle placement patterns with further example anti-rotation features, according to aspects of the present disclosure. [Figure 12] 1 is a flow chart illustrating a method for mounting a needle connector to a reusable injector, according to an aspect of the present disclosure. [Figure 13] FIG. 1 is a perspective view of a modular needle connector according to an aspect of the present disclosure. [Figure 14A] 1 illustrates an exemplary disk of a modular needle connector according to aspects of the present disclosure. [Figure 14B] 1 illustrates an exemplary disk of a modular needle connector according to aspects of the present disclosure. [Figure 15A] 1 illustrates an exemplary connector body of a modular needle connector according to aspects of the present disclosure. [Figure 15B] 1 illustrates an exemplary connector body of a modular needle connector according to aspects of the present disclosure. [Figure 16A] FIG. 13 is a side cross-sectional view of an assembled modular needle connector according to aspects of the present disclosure. [Figure 16B] FIG. 13 is a side cross-sectional view of an assembled modular needle connector according to aspects of the present disclosure. [Figure 17A] 1A-1C are side views of an exemplary method of mounting a modular needle connector to a reusable injector, according to aspects of the present disclosure. [Figure 17B] 1A-1C are side views of an exemplary method of mounting a modular needle connector to a reusable injector, according to aspects of the present disclosure. [Figure 18] 13 is a flow chart illustrating a method for installing and removing a modular needle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] The solution disclosed herein relates to a multi-dose injection system for delivering drugs, hormones, biologics, and other therapeutic agents. In particular, the solution describes a modular, attachable needle connector that pierces the septum of a reusable injector at various locations. As mentioned above, current methods for administering a multi-dose injection regimen mostly include a reusable injector containing the therapeutic injection and multiple needle connectors that can be attached to the distal end of the injector for each injection. The reusable injector can have several doses of the therapeutic agent, and thus the system can include as many needles as needed for the entire regimen. For example, it is common for systems to provide seven needle connectors for a one-week regimen, 14 needle connectors for a two-week regimen, and so on.

[0044] One problem with current systems is that the same location on the septum of a reusable injector is repeatedly damaged. It has been shown that repeatedly piercing / puncturing the same location on the septum can degrade the rubber material of the septum. This, in turn, can cause the therapeutic agent placed within the reusable injector to become contaminated by debris from the degraded rubber of the septum. Naturally, this is not ideal for a system that contains drugs, hormones, biologics, or other agents that are injected into a patient.

[0045] The devices, systems, and methods described herein provide a solution to this contamination problem by limiting the number of times the septum is pierced at any given location. Various devices and methods have been disclosed for providing an injection system with multiple needle connectors, examples of which will now be described with reference to the accompanying drawings. FIG. 1 is a side view of a needle connector assembly 100 according to an embodiment of the present disclosure. The needle connector assembly 100 may include a needle connector 102. The needle connector 102 may have a casing 103 that may secure the needle connector 102 to a reusable injector (e.g., the reusable injector 302 shown in FIGS. 3A and 3B) and protect the proximal end 108 of the needle 104.

[0046] The needle connector 102 may include a needle 104 that can be used to pierce a septum 308 of the reusable injector 302 and pierce the skin of a patient to deliver a therapeutic agent. For example, the needle 104 may have a distal end 106 extending from the casing 103, or a protrusion 105 also extending from the casing 103. The distal end 106 of the needle 104 may be used to pierce the skin of a patient to deliver a therapeutic agent, for example, subcutaneously. The needle connector 102 may include the aforementioned protrusion 105 that provides lateral stability to the distal end 106 of the needle 104 so that the end of the needle 104 that is inserted into the patient can be further secured. The needle 104 may have a proximal end 108 that extends into the casing 103 and pierce a septum 308 of the reusable injector 302, as described in more detail below.

[0047] The needle connector 102 may also include an anti-rotation feature 110 that can ensure that the proximal end 111 of the needle connector 102 is properly positioned relative to the reusable injector 302. In previous systems, reusable injectors and needle connectors have generally had a circular cross-section. The needle of previous needle connectors was positioned centrally (e.g., concentrically) in the outer casing of the needle connector and was intended to pierce the center of a circular septum. This allowed the needle connector to be rotated and attached to the injector in any position since the needle would pierce the septum in the same location regardless of rotation. With the current systems and methods, the proximal end 108 of the needle 104 can be positioned in a variety of positions. To this end, the anti-rotation feature 110 of the needle connector 102, in conjunction with a corresponding anti-rotation feature of the reusable injector 302 (e.g., anti-rotation feature 306 shown in FIGS. 3A and 3B), can ensure that the piercing location on the septum 308 is the intended piercing location. The anti-rotation feature 110 is discussed in more detail below.

[0048] The needle connector assembly 100 may include a needle protector 112. The needle protector 112 may be a removable housing for the distal end 106 of the needle 104 that extends from the needle connector 102. The needle protector 112 may be dimensioned to engage with the protrusion 105, for example. The needle protector 112 may provide a degree of safety to the patient by ensuring that the needle 104 is not exposed before the patient requires access to the needle 104.

[0049] The needle connector assembly 100 may include a connector cap 114. The connector cap 114 may be used to protect the needle connector 102 and the needle protector 112 during shipping and handling. The connector cap 114 may also be used to ensure sterility of the needle connector 102. For example, the connector cap 114 may be dimensioned to extend and be disposed over the casing 103 such that it may enclose the distal end 106 of the needle and the casing 103. A seal (e.g., paper, plastic, foil, etc.) may be disposed at the end of the connector cap 114 proximate the proximal end 111 of the needle connector 102 such that the entire needle connector 102 may be sealed for sterility preservation.

[0050] 2A-2C are side views of needle connectors 102 according to aspects of the present disclosure. The examples shown in FIGS. 2A-2C illustrate various arrangements and / or shapes of needles 104 within corresponding needle connectors 102. As discussed above, the casing 103 of each needle connector 102 can be dimensioned to engage a reusable injector 302 (e.g., at the distal end 304 of the reusable injector 302, as shown in FIGS. 3A and 3B). As shown in FIG. 2A, the needle 104 can be centered within the casing 103 and extend vertically. With this design, the distal end 106 of the needle 104 is centered within the needle connector 102, and the proximal end 108 of the needle 104 is correspondingly centered (e.g., concentric) relative to the distal end 304 of the reusable injector 302.

[0051] Alternatively, the proximal end 108 of the needle 104 may be located at other positions within the casing 103 such that the proximal end 108 of the needle 104 corresponds to a non-centered position of the distal end 304 of the reusable injector 302. In the example shown in FIG. 2B, this is accomplished by providing a curve 202 on the needle 104 located between the proximal end 108 and the distal end 106 of the needle 104. The curve 202 may be offset as shown, or may be a curve within the needle. With this design, the distal end 106 of the needle 104 is centered within the needle connector 102, but the proximal end 108 is non-centered within the casing 103. This allows the proximal end 108 of the needle 104 shown in FIG. 2B to pierce a different position on the septum 308 than the proximal end 108 of the needle 104 shown in FIG. 2A.

[0052] The curved portion 202 of the needle 104 may be secured within the casing 103, for example, by a curved portion protection layer 204 disposed within the needle connector 102. The interior of the casing 103 may be generally hollow for connection to the distal end 304 of the reusable injector 302. The curved portion protection layer 204 may be a solid layer within the material of the casing 103 to encase and protect the curved portion 202 of the needle 104. This, of course, may prevent the needle 104 from bending as it is inserted into the septum 308, since the proximal end 108 may extend perpendicularly from the curved portion protection layer 204 to the septum 308.

[0053] 2C, the proximal end 108 may be offset within the casing 103 by providing a vertical needle 104 while offsetting the entire needle 104 (i.e., no curve 202 in the design). With this design, the same result can be achieved for the proximal end 108 of the needle 104, but the distal end 106 of the needle 104 may also be offset relative to the casing 103. This design may eliminate the need for the curve protection layer 204, as the needle 104 may not be as prone to bending as when it is inserted into the septum 308.

[0054] 3A and 3B are perspective views of a needle connector 102 and a corresponding reusable injector 302 according to an embodiment of the present disclosure. The injection system 300 described herein includes at least two components: a reusable injector 302 and a needle connector 102 positionable on and attachable to the reusable injector 302. Although the injection system shown in FIGS. 3A and 3B shows only a single needle connector 102, the injection system 300 can be used multiple times and thus includes multiple needle connectors 102. The proximal end 111 of the needle connector 102 can have a cross-sectional geometry that corresponds to the cross-sectional geometry of the distal end 304 of the reusable injector 302 such that the two can be connected by axially sliding the needle connector 102 over the reusable injector 302.

[0055] Also note that an example needle connector 102 can be threadably engaged with a reusable injector 302. When the needle connector 102 is threaded, the threads provide the proper position. Another example has an anti-rotation feature 110 on the needle connector 102 that, when fully threaded or mid-threaded, engages with an anti-rotation feature 306 on the reusable injector 302 to reposition the proximal end 108 of the needle 104 in a designated position on the septum 308.

[0056] The perspective views of Figures 3A and 3B provide an unobstructed view of how the proximal end 108 of each needle 104 may be inserted into the septum 308 of the reusable injector 302. As can be seen in both figures, the proximal end 108 of the needle 104 may be offset from the center of the septum 308, similar to the example shown in Figures 2B and 2C. Alternatively, the proximal end 108 of the needle 104 may be positioned to correspond to the center location of the septum 308, similar to the example shown in Figure 2A.

[0057] In some examples, the tip of the proximal end 108 of the needle 104 may be slightly recessed into the casing 103. Stated another way, the tip of the proximal end 108 of the needle 104 may not extend all the way to the proximal end 111 of the needle connector 102. This may provide a level of safety to prevent a user from inadvertently piercing themselves with the needle 104. The recessed needle 104 may also provide some tolerance when the needle connector 102 is slid onto the distal end 304 of the reusable injector 302. For example, when the needle connector 102 is attached to the reusable injector 302, if the proximal end 108 of the needle 104 is slightly recessed, the proximal end 111 of the needle connector 102 may extend to a greater extent above the distal end 304 of the reusable injector 302 before the proximal end 108 of the needle 104 engages the septum 308. This may also facilitate engagement of the anti-rotation features 110 / 306 described herein.

[0058] The proximal end 108 of the needle 104 can also be manufactured to further facilitate protection of the septum 308. For example, the tip of the proximal end 108 of the needle 104 can be of a non-coring design to prevent the generation of rubber particles when piercing the septum 308.

[0059] 3A, the distal end 304 of the reusable injector 302 may have a circular cross-section that may fit into the proximal end 111 of the needle connector 102, which may also have a circular cross-section. In these examples, the proximal end 111 of the needle connector 102 may be concentrically disposed on the distal end 304 of the reusable injector 302. The needle connector 102 and / or the reusable injector 302 may include an anti-rotation mechanism to ensure that they are properly aligned. If the proximal ends 108 of the needles 104 are disposed in different positions such that the two needle connectors 102 may pierce the septum 308 at different positions, the anti-rotation mechanism may ensure that the piercing location on the septum 308 is the intended piercing location.

[0060] The needle connector 102 may include a first anti-rotation feature 110 and the reusable injector 302 may include a second anti-rotation feature 306. The first anti-rotation feature 110 and the second anti-rotation feature 306 may be a key / keyway pair, as shown in FIG. 3A. For example, the anti-rotation feature 110 of the needle connector 102 may be a key that is sized to engage with the anti-rotation feature 306 of the reusable injector 302 (which may be a keyway). Of course, the reverse may also be true, and the anti-rotation feature 306 of the reusable injector 302 may be a key that engages with a keyway of the needle connector 102. Other anti-rotation features 110 / 306, such as raceways, splines, etc., are also possible. Another example includes a partial flat space in cross section where the rest of the casing 103 is circular that abuts a flat surface in cross section where the rest of the reusable injector 302 is circular (e.g., the example shown in FIG. 9).

[0061] 3B, the anti-rotation feature of the needle connector 102 and the anti-rotation feature of the reusable injector 302 can be the cross-sectional geometry of the two components instead of being separate features such as a key / keyway. Using the example shown in FIG. 3B, the distal end 304 of the reusable injector 302 can be square or rectangular, and the proximal end 111 of the needle connector 102 can be square or rectangular and sized to engage with the reusable injector 302. By providing a non-circular cross-section, the positions / orientations in which the needle connector 102 can be placed on the reusable injector 302 may be limited. For example, if both are square, only four orientations are possible, and if both are rectangular, only two orientations are possible. The cross-sectional geometry of the two devices can be any other non-circular shape, including but not limited to triangular, trapezoidal, pentagonal, hexagonal, and other cross-sectional geometries.

[0062] 4A-4C are side views of an exemplary method of mounting a needle connector 102 to a reusable injector 302, according to an embodiment of the present disclosure. As discussed above, an injection system may include multiple needle connectors 102 for each injection regimen and at least one reusable injector 302 for providing a therapeutic agent (e.g., a drug, hormone, biologic, etc.). FIGS. 4A-4C show a method of mounting a single needle connector 102 having an offset relative to the proximal end 108 of the needle 104. However, as discussed above, multiple needle connectors 102 can be provided to a patient as a kit to encompass an entire injection regimen (e.g., one week of daily administration, two weeks of daily administration, or any other regular injection regimen). Additionally, although the needle connector 102 of FIGS. 4A-4C has an offset (i.e., non-centered) proximal end 108 of the needle 104, the same process can be used for any of the needle connector 102 configurations described herein.

[0063] In FIG. 4A, the connector cap 114, including the needle protector 112 and the needle connector 102, is placed adjacent the distal end 304 of the reusable injector 302. As described above, this step may be preceded by removing a protective seal from the end of the connector cap 114. The assembly of the connector cap 114, needle protector 112, and needle connector 102 is then slid axially onto the distal end 304 of the reusable injector 302. FIG. 4A illustrates an exemplary reusable injector 302 having an anti-rotation feature 306 that is a keyway, in accordance with the present disclosure. The keyway can be dimensioned to engage with a key (i.e., the anti-rotation feature 110 of the needle connector 102) located on the needle connector 102. The anti-rotation feature 306 / 110 can also aid in the placement of the needle connector 102 as it is pushed axially into the reusable injector 302, for example, by acting as a track to guide the placement of the needle connector 102.

[0064] The systems described herein may include mechanical attachments that removably secure the needle connector 102 to the reusable injector 302. These attachments may ensure that the needle connector 102 is not inadvertently separated from the reusable injector 302, for example, when the patient is withdrawing the needle 104 from the skin. As noted above, previous injection system designs have utilized a centrally located needle that pierces the septum 308 at a central location. As such, the systems may, and typically do, include threads on the needle connector 102 and reusable injector 302 for mechanical attachment.

[0065] However, other designs can be used with the systems and methods described herein. Because the proximal end 108 of the needle 104 can be located in a variety of predetermined positions, rotating the needle connector 102 relative to the reusable injector 302 to engage the threads may not be desirable and could damage the needle 104. Instead, the distal end 304 of the reusable injector 302 can have a taper 402 (e.g., a Morse taper) that can be dimensioned to engage a corresponding taper (not shown in FIG. 4A) on the needle connector 102 to provide a slight mechanical fit between the two components. In other examples, other mechanical attachments 403 can be applied to one or both of the components, such as ribs, cantilevers, or other mechanical mechanisms to snap the two components together.

[0066] The reusable injector 302 may function as a cartridge for storing a therapeutic agent 404. The therapeutic agent 404 may be a drug, hormone, biologic, or other agent intended to be injected into a patient through the needle 104 of the needle connector 102. The therapeutic agent 404 may be a liquid or powder that is reconstituted with a liquid also stored in the reusable injector 302.

[0067] As shown in FIG. 4B, after the needle connector 102 is seated on the distal end 304 of the reusable injector 302, the connector cap 114 can be removed from the needle connector 102. If the system includes a needle protector 112, the needle protector 112 can now be exposed and the needle 104 can be capped and protected. As mentioned above, the exemplary system of FIG. 4B includes an offset proximal end 108 of the needle 104. This can allow the proximal end 108 to pierce the septum 308 (not shown) at an off-center location. As shown in FIG. 4C, the needle protector 112 can be removed to access the distal end 106 of the needle 104 and a therapeutic agent 404 can be administered to the patient.

[0068] 5A-11 are end views of example placements of the proximal end 108 of the needle 104 within the needle connector 102 according to embodiments of the present disclosure. These figures illustrate non-limiting examples of relative offsets that may be imparted to the needle connector 102. The placement of the proximal end 108 of the needle 104 also corresponds to a piercing location on the septum 308 (not shown in FIGS. 5A-11), and the figures also show the corresponding piercing location.

[0069] FIG. 5A shows an example of a needle arrangement and corresponding index 500 on the proximal end 108 of the needle connector 102. The index 500 may be provided to inform the patient which needle connector 102 to use for the injection regimen. It is contemplated that multiple needle connectors 102 may be provided as a kit, either alone or in combination with the reusable injector 302. The kit may include all the needle connectors 102 needed to complete the injection regimen of the reusable injector 302. For example, if the regimen is a one-week regimen, the kit may include seven needle connectors 102. If the regimen is a two-week regimen (as shown in FIGS. 5A and 5B), the kit may include fourteen needle connectors 102. The needle connectors 102 may be indexed 500, for example, by indicating the consecutive days on which the needle connectors 102 are to be used (e.g., day 1, day 2, etc., as shown in FIG. 5A). Alternatively, the needle connectors may be indexed 500 by days of the week (eg, Monday, Tuesday, etc.).

[0070] However, it is not necessary to index the needle connectors 102 for any particular day. One objective of the systems and methods described herein is to limit the number of times the septum 308 is pierced at any given location. To this end, the kit can limit the number of needle connectors 102 having a proximal end 108 needle arrangement at any given location such that the septum 308 cannot be pierced more than a predetermined number of times. It has been shown that piercing the septum 308 more than a certain number of times can cause degradation of the rubber material of the septum 308. Depending on the material from which the septum 308 is manufactured, this number can vary. For example, it has been shown that some materials can cause degradation if the septum 308 is pierced more than five times. In this example, the kit can include no more than five needle connectors 102 having the same proximal end 108 needle location.

[0071] 5A for illustration, this example shows seven different configurations of proximal end 108 needle placements, and the kit does not include more than two needle connectors 102 having the same proximal end 108 needle placement. In this example, the patient cannot pierce the septum 308 more than twice at any given location, so there is no need to index the kit 500. It will be understood that the above illustrations are for illustrative purposes and are not intended to be limiting, as other materials may require two or less, three or less, four or less, six or more needle connectors 102 having the same proximal end 108 needle placements.

[0072] 5B shows an end view of a system including 14 needle connectors 102 divided into seven different sets of needle connectors 102, with each set having two needle connectors 102 with the same proximal end 108 needle arrangement. As shown, one of the proximal end 108 needle arrangements may be located at the center of the casing 103 corresponding to the center of the septum 308. If the casing 103 and reusable injector 302 have a circular cross section, this may mean that the proximal end 108 needle arrangement is concentric with the distal end 304 of the reusable injector. The other proximal end 108 needle arrangements may be offset at a different position within the casing 103 (i.e., non-concentric if circular). For example, if the needle connectors 102 include an anti-rotation feature 110, any proximal end 108 needle arrangement may be offset from the anti-rotation feature 110 by a radial offset 502. Additionally, the first set of needle connectors 102 (e.g., the 5th and 6th set in FIG. 5B) may be offset from the second set of needle connectors (e.g., the 7th and 8th set in FIG. 5B) by a predetermined radial offset 502. Additionally, FIG. 5A is an end view showing the placement of the proximal ends 108 of the needles within the casing 103, which may also show the corresponding piercing locations on the septum 308. FIG. 5B is a similar end view, and is a schematic diagram showing several positions of needle placement of the proximal ends 108 within the casing 103 and / or septum 308.

[0073] 6A and 6B show an alternative example where the kit includes 14 different needle connectors 102, each with a different proximal end 108 needle placement. In this example, the septum 308 may only be pierced once at any one location. In these cases, the radial offset 502 may be smaller than the radial offset 502 depicted in FIGS. 5A and 5B to accommodate more piercing locations. FIG. 6A is an end view showing the placement of the proximal end 108 of the needles within the casing 103, which may also show the corresponding piercing locations on the septum 308. FIG. 6B is a similar end view, but is a schematic diagram showing several locations of the proximal end 108 needle placement within the casing 103 and / or septum 308.

[0074] FIG. 7 illustrates an alternative proximal end 108 needle placement layout in which placements are radially set on the outer annulus 702 and the inner annulus 704. Depending on the size (i.e., gauge) of the needle 104 relative to the size (e.g., surface area) of the septum 308, the needle placements on the proximal end 108 may need to be staggered instead of being in a single annulus (e.g., the placements shown in FIGS. 5A-6B are set in a single annulus). For example, in FIG. 6B, if the gauge of the needle 104 were to be increased slightly, the piercing locations could overlap, potentially damaging the material of the septum 308. In FIG. 7, the proximal end 108 of the needle is placed (a) in the center of the casing 103, (b) radially along the outer annulus 702, and (c) radially along the inner annulus 704, ensuring that the piercing locations remain separated and non-overlapping.

[0075] 8 illustrates an example embodiment in which a set of needle connectors 102 includes more than two connectors having the same needle configuration at the proximal end 108. As discussed above, in some instances, the septum 308 may not be damaged by inserting the proximal end 108 of the needle 104 into the septum 308 a certain number of times or less. FIG. 8 illustrates an example in which each set includes three needle connectors 102 having the same needle configuration at the proximal end 108. Of course, this number may vary depending on the needs of the system and the material of the septum 308.

[0076] 9-11 are end views of the needle connector 102 having various cross-sectional geometries. As shown in FIG. 9, the casing 103 is circular except for a flat section, which may be an anti-rotation feature 110 of the needle connector 102 that ensures proper positioning of the needle connector 102 on the distal end 304 of the reusable injector 302. The flat section (i.e., the first anti-rotation feature 110) may correspond to a flat section (i.e., the second anti-rotation feature 306) on the reusable injector 302 to ensure proper positioning of the needle connector 102 so that the proximal end 108 of the needle 104 pierces the septum 308 at the desired location.

[0077] FIG. 10 illustrates an exemplary system in which the needle connector 102 (i.e., the casing 103 of the needle connector 102) has a square cross-section. In this example, the anti-rotation feature 110 of the needle connector 102 is the cross-sectional geometry of the needle connector 102 in combination with the cross-sectional geometry of the distal end 304 of the reusable injector 302, which may also be square. FIG. 11 also illustrates a needle connector 102 design in which another cross-sectional geometry of the casing 103 (e.g., pentagonal) may function as the anti-rotation feature 110 of the needle connector 102. As discussed above, the cross-sectional geometry of the casing 103 is, of course, not limited to a square or pentagonal, but may include, but is not limited to, trapezoidal, hexagonal, and other cross-sectional geometries.

[0078] 12 is a flow chart illustrating a method 1200 of mounting a needle connector to a reusable injector according to aspects of the present disclosure. The steps of the method of FIG. 12 can be performed by any of the exemplary means described herein or by similar means, as will be appreciated. With reference to the method 1200 outlined in FIG. 12, in step 1205, a first needle connector can be selected for a first injection regimen. The first injection regimen can be associated with a first injection of a multiple injection regimen.

[0079] In step 1210, the method 1200 may include disposing a first needle connector proximate to a distal end of a reusable injector. This step may be similar to the example shown in FIG. 4A above. In step 1215, the method 1200 may include piercing a septum of the reusable injector with a proximal end of a first needle of the first needle connector at a first location on the septum. To illustrate the steps, this piercing of the septum may be completed with the example of the needle connector shown in FIG. 6B, and the first injection regimen may correspond to "day 1" (or any other "day" in this example).

[0080] In step 1220, the method 1200 may include administering the first injection regimen to the patient. This may be completed, for example, by inserting a distal end of a needle into the patient's skin. Stated differently, the injection regimen may be administered subcutaneously, intravenously, etc. In step 1225, the method 1200 may include removing the first needle connector from the reusable injector.

[0081] Steps 1230-1245 may be similar to steps 1205-1220 described above, but with a different second needle connector. In particular, in step 1230, the method 1200 may include selecting a second needle connector for the second injection regimen. In step 1235, the method 1200 may include positioning the second needle connector proximate to a distal end of the reusable injector. In step 1240, the method 1200 may include piercing the septum at a second location on the septum with a proximal end of a second needle of the second needle connector. In step 1245, the method 1200 may include administering the second injection regimen to the patient. The first location and the second location are different locations. Illustratively, if the first needle connector described in step 1215 corresponds to the connector "Day 1" of FIG. 6B, the second needle connector may correspond to any other "Day" of FIG. 6B. The method 1200 may end after step 1245. In other embodiments, additional steps according to the examples above may be performed.

[0082] The needle connector examples described above provide a solution to the problem of particle generation by providing multiple needle connectors that pierce the septum of a reusable injector at various locations. Another solution to particle generation includes providing a single needle connector with various needle positions to vary the puncture site on the septum. The systems and methods of the present invention can also provide this solution by employing a single modular rotating needle connector that varies the needle position.

[0083] 13 is a perspective view of a modular needle connector 1300 according to an embodiment of the disclosure. The modular needle connector 1300 may include a disk 1402 disposed within a connector body 1502. The disk 1402 may rotate within the connector body 1502 such that a needle 1404 within the disk 1402 may move position relative to the connector body 1502. As described below, this behavior of the needle 1404 relative to the connector body 1502 allows for random needle placement within the septum 308 of the reusable injector 302 and allows the connector body 1502 to be unscrewed from the reusable injector 302 when the needle 1404 is inside the septum 308. The needle 1404 may remain in the puncture position (and retract axially) as the disk 1402 rotates.

[0084] 14A and 14B illustrate an exemplary disk 1402 of a modular needle connector 1300 according to an embodiment of the present disclosure. FIG. 14A is a side view of the disk 1402, and FIG. 14B is a perspective view of the disk 1402. The needle 1404 may be positioned within the disk 1402 at an off-center location from the center 1412. For example, the needle opening 1406 may be positioned within the disk 1402 at a location that is not concentric with the center 1412 of the disk 1402. As described below, this non-concentric positioning of the needle 1404 may facilitate random positioning of the needle 1404 within the septum 308. The disk 1402 may also include an axis 1413 that passes through the center 1412 if the disk 1402 is circular. The disk 1402 may be rotatable about the axis 1413. The needle 1404 may be offset from the axis 1413 that passes through the center 1412 of the disk 1402. As described in more detail below, the axis 1413 may also be coaxial with the axis of the septum 308 (e.g., axis 1704).

[0085] The needle 1404 may have a proximal end 1408 and a distal end 1410. The distal end 1410 may extend from a first side 1414 of the disk 1402, and the proximal end 1408 may extend from a second side 1416 of the disk 1402. The proximal end 1408 may extend into the connector body 1502 so that it may be inserted into a septum 308 of the reusable injector 302, as described below. The proximal end 1408 and the distal end 1410 of the needle 1404 may be a single component that extends through the needle opening 1406, for example, a single needle with a tip on both ends. In other examples, the proximal end 1408 and the distal end 1410 of the needle 1404 may be two separate pieces that are coupled to each other proximate the needle opening 1406.

[0086] The tips of both the proximal end 1408 and the distal end 1410 of the needle 1404 may serve different purposes, namely piercing the septum and piercing the skin, respectively. To this end, the tip of each portion of the needle may be tailored for its specific purpose. For example, the distal tip of the distal end 1410 may include a beveled tip 1450, which is a common type of needle tip for skin piercing. Of course, any other needle tip may be used for the distal end 1410 of the needle 1404. The proximal end 1408 may be tailored to prevent particle generation due to piercing the septum 308. For example, the tip of the proximal end 1408 may be a non-coring needle tip. Non-coring needle types may include a variety of shapes, including non-sharp tip shapes, needles curved at 45 degrees to prevent the bevel from coring the septum 308. One example of a tip at the proximal end 1408 is a needle with a blunt tip 1452 having a side mounted fluid inlet 1454. Because the needle's fluid inlet 1454 is located on the side of the needle rather than at the tip, the likelihood of coring the septum 308 is reduced, but therapeutic agent can still be drawn into the needle 1404.

[0087] 15A and 15B illustrate an exemplary connector body 1502 of a modular needle connector 1300 according to an embodiment of the disclosure. FIG. 15A is a perspective view of the connector body 1502, and FIG. 15B is a side cross-sectional view of the connector body 1502. The connector body 1502 can include a disk slot 1504 located near a first end 1506 of the connector body 1502. The disk slot 1504 can be dimensioned to receive the disk 1402. For example, the disk slot 1504 can be circular to accommodate a circular disk 1402. The circular disk 1402 can allow the disk 1402 to rotate within the disk slot 1504. Providing sufficient tolerance between the dimensions of the disk 1402 and the disk slot 1504 can further facilitate rotation of the disk 1402. For example, the first height 1420 and first diameter 1430 of the circular disc 1402 can be smaller than the second height 1560 and second diameter 1570 of the disc slot 1504 such that the disc 1402 is rotatable within the disc slot 1504. The disc slot 1504 can be defined on one side by a lower ridge 1520 facing the injector housing 1508 and on the other side by an upper ridge 1522 facing the first end 1506 of the connector body 1502 (the upper ridge 1522 facing the skin during injection).

[0088] The connector body 1502 may define an injector housing 1508 at a second end 1510 of the connector body 1502. The injector housing 1508 may be an interior cavity of the connector body 1502 that receives the reusable injector 302. Referring to FIG. 15B for illustration, the injector housing may extend from the second end 1510 of the connector body 1502 to a lower ridge 1520 proximate the disk slot 1504. The injector housing 1508 may include features that allow the connector body 1502 to be attached to and detached from the reusable injector 302. For example, the connector body 1502 may include wings 1512 that extend along at least a portion of the length of the injector housing 1508. The wings 1512 may be individual protrusions extending across the injector housing 1508 that may be separated by notches 1514 between the wings 1512. The wings 1512 may be flexible such that when the connector body 1502 is lowered onto the reusable injector 302, the wings flex outward and provide a snap mechanism on the distal end 304 of the reusable injector 302. Thus, the wings 1512 allow the connector body 1502 to be lowered axially onto the reusable injector 302 without having to twist or thread the connector body 1502 onto the injector.

[0089] The inner surface 1516 of the injector housing 1508 may also include additional attachment features to ensure that the connector body 1502 is securely connected to the reusable injector 302. For example, the inner surface 1516 may include threads 1518 that may be dimensioned to engage threads on the distal end 304 of the reusable injector 302 (e.g., threads 1702 in FIG. 17A ). As described in more detail below, the combination of the wings 1512 and the threads 1518 allows for a variety of attachment / detachment mechanisms for the modular needle connector 1300 (e.g., axial pushing for attachment, unscrewing for removal, etc.).

[0090] 16A is a side cross-sectional view of an assembled modular needle connector 1300 (e.g., the modular needle connector shown in FIG. 13) according to an embodiment of the present disclosure. When assembled, the disk 1402 may be placed into the disk slot 1504. The distal end 1410 of the needle 1404 may face the outside of the injector housing 1508. The proximal end 1408 of the needle 1404 may face inward, i.e., toward the inside of the injector housing 1508. It is contemplated that the disk 1402 may be inserted into the disk slot 1504 in a multi-step process. For example, the connector body 1502 may be manufactured in two separate pieces. The disk 1402 may be inserted into the respective disk slot 1504 of each piece, and the two pieces may be glued, heat welded, or the like, together to create the structure shown in FIG. 16A. In other examples, one or both of the upper ridge 1522 or the lower ridge 1520 can be tilted so that sufficient axial force can be applied to the disk 1402 to push the disk 1402 in one direction into the disk slot 1504 but prevent the disk 1402 from being removed once inserted.

[0091] As discussed above, the disk 1402 may be rotatable relative to the connector body 1502. This may allow for varying the piercing location on the septum 308 discussed above with respect to Figures 6A-11. Using Figure 6B for illustration, the embodiments discussed above with respect to multiple needle connectors included different needle connectors 102 having different needle arrangements within the casing 103. Thus, the septum 308 may be pierced at different locations using the different needle connectors 102.

[0092] The modular needle connector 1300 allows the goal of varying puncture locations to be achieved using a single device. For example, because the disk 1402 rotates freely, the proximal end 1408 of the needle can change position from a first position in the injector housing 1508 to a second position in the injector housing 1508 by rotation of the rotating disk 1402. This means that no matter what orientation the user places the modular needle connector 1300 relative to the distal end 304 of the reusable injector 302, the placement of the proximal end 1408 of the needle 1404 is random. This means that any of the needle placements shown in FIG. 6A can be achieved by the same device, i.e., the modular needle connector 1300.

[0093] Randomizing the placement of the proximal end 1408 of the needle 1404 can accomplish the goal of varying the puncture location on the septum 308. Statistical analysis has shown that if the placement of the proximal end 1408 of the needle 1404 relative to the septum 308 is completely random, the probability of piercing the septum 308 multiple times at the same location is minimal. Furthermore, the number of times the septum 308 can be pierced at the same location before particle generation occurs depends on many factors, such as the material used for the septum 308 and, in particular, the type of needle inserted into the septum 308. Randomizing the placement of a non-coring needle, such as a blunt tip 1452 or another non-coring needle, can reduce the occurrence of particle generation in the reusable injector 302.

[0094] In addition to the above example of FIG. 16A, the first side 1414 of the disk 1402 and the distal side 1505 of the disk slot 1504 may have matching interlocking teeth 1407, 1507 as shown in FIG. 16B. When the needle 1404 of the modular needle connector 1300 is upright, the fine teeth 1407, 1507 are not engaged. When upright, the second side 1416 rests on the disk slot 1504 with a slight gap between the first side 1414 and the distal side 1505 of the disk slot 1504. When the modular needle connector 1300 is placed on the distal end 304 of the reusable injector 302 and the reusable injector 302 is inverted for the user to perform an injection, the teeth 1407, 1507 are engaged. The engagement of the teeth 1407, 1507 adds additional friction and prevents any movement of the disk 1402 within the disk slot 1504 during the crucial injection period. The teeth 1407, 1507 are very fine and still allow for nearly infinite positioning of the rotating disk 1402. When the reusable injector 302 is returned to an upright position again after injection, the teeth 1407, 1507 disengage and the disk 1402 is again free to rotate during rotation of the modular needle connector 1300 off the reusable injector 302. The teeth 1407 may also be located on a second side 1416 of the disk 1402 in a similar manner as described above.

[0095] 17A and 17B are side views of an exemplary method of mounting a modular needle connector 1300 to a reusable injector 302, according to an embodiment of the present disclosure. As shown in FIG. 17A, the modular needle connector 1300 may be disposed near the distal end 304 of the reusable injector 302. The rotating disk 1402 of the modular needle connector 1300 may have an axis 1413 passing through a center 1412 of the disk 1402. The axis 1413 of the disk 1402 may be coaxial with an axis 1704 passing through the septum 308 (e.g., if the septum 308 is circular, e.g., as shown in FIG. 3A). However, the needle 1404 of the modular needle connector 1300 may be off-axis from the axis 1413 of the disk 1402 and the axis 1704 of the septum 308.

[0096] The modular needle connector 1300 may be advanced axially onto the distal end 304 until the proximal end 1408 of the needle 1404 contacts the septum 308 of the reusable injector 302. The modular needle connector 1300 may then be advanced further such that the proximal end 1408 of the needle 1404 advances through the septum 308 as the modular needle connector 1300 is seated. At a certain point in the assembly of the device, the first threads 1518 of the connector body 1502 may contact the second threads 1702 of the distal end 304 of the reusable injector 302.

[0097] At this point, continued axial pressure on the modular needle connector 1300 may cause the wings 1512 of the connector body 1502 to bend or flex outwardly, thereby overcoming the contact between the first thread 1518 and the second thread 1702 and fully seating the modular needle connector 1300. Full seating of the modular needle connector 1300 may occur, for example, when the distal end 304 of the reusable injector 302 contacts the lower ridge 1520 of the connector body 1502 or when the second end 1510 of the connector body 1502 abuts a surface of the distal end 304 of the reusable injector 302. The force required to overcome the contact between the first thread 1518 and the second thread 1702 may vary depending on the quantity of wings 1512 on the connector body 1502. For example, the connector body 1502 may include four wings 1512, as shown in FIG. 17A. In other examples, a fewer number of wings 1512 may be formed on the connector body 1502. If the material from which the connector body 1502 is manufactured is soft / flexible enough, two wings 1512 may be sufficient to seat the connector body 1502 on the threads. If the material from which the connector body 1502 is manufactured is harder, more than four wings 1512 may be formed on the connector body 1502, such as five or more wings.

[0098] 17B shows the modular needle connector 1300 fully seated on the reusable injector 302. At this point, the reusable injector 302 can be used to administer a therapeutic agent to a patient. Once the injection is complete, the modular needle connector 1300 can be removed from the reusable injector 302. This can be accomplished by unscrewing the modular needle connector 1300 from the reusable injector 302. For example, the first threads 1518 of the connector body 1502 can be unscrewed from the second threads 1702 of the reusable injector 302.

[0099] Rotating the connector body 1502 relative to the reusable injector 302 may cause the disk 1402 to rotate relative to the connector body 1502. Stated another way, the positioning of the needle 1404 within the septum 308 may remain constant, and as the connector body 1502 is unscrewed, the proximal end 1408 of the needle 1404 is withdrawn axially from the puncture hole in the septum 308, which is facilitated by the rotation of the disk 1402. The modular needle connector 1300 can then be removed from the reusable injector 302.

[0100] 17A and 17B can be repeated for subsequent doses of therapeutic agent using the same modular needle connector 1300. For the subsequent dose, the modular needle connector 1300 can be positioned near the distal end 304 of the reusable injector 302. The modular needle connector 1300 can then be advanced axially onto the distal end 304 until the proximal end 1408 of the needle 1404 contacts the septum 308 of the reusable injector 302. Because the placement of the proximal end 1408 of the needle 1404 is random due to the rotatability of the disk 1402, the location of the proximal end 1408 of the needle 1404 is random and therefore may be in a different location than the previous dose. This process can be repeated as many times as there are doses contained in the reusable injector 302, for example, 14 times for a 14-day regimen. Each of these 14 assemblies has a random needle placement relative to the septum 308 .

[0101] It should be noted that the process described with respect to Figures 17A and 17B includes a two-step assembly / removal process. For assembly, the modular needle connector 1300 can be advanced axially and the wings 1512 can facilitate advancement over the threads (e.g., the first thread 1518 and the second thread 1702). For removal, the modular needle connector 1300 can be unscrewed. However, the disclosure is not limited to this series. For example, the device can be assembled by advancing the modular needle connector 1300 until the proximal end 1408 of the needle 1404 contacts the septum 308, followed by engaging the first thread 1518 with the second thread 1702. The modular needle connector 1300 can then be fully seated by threading the modular needle connector 1300 into the reusable injector 302.

[0102] FIG. 18 is a flow chart illustrating a method 1800 of mounting a modular needle connector to an injector, according to an aspect of the disclosure. The steps of the method of FIG. 18 can be performed by any of the exemplary means described herein or by similar means, as will be appreciated. With reference to the method 1800 outlined in FIG. 18, in step 1805, the modular needle connector can be positioned proximate to a distal end of the injector. Step 1810 can include piercing a septum of the injector at a first location. A proximal end of a needle in the modular needle connector can pierce the septum. The needle can be connected to a rotating disk in the modular needle connector.

[0103] Step 1815 may include axially advancing the modular needle connector into the distal end of the injector. In this step, the proximal end of the needle may be advanced into the septum. The modular needle connector may be advanced until the connector seats in the distal end of the injector.

[0104] Step 1820 may include rotating a connector body of the modular needle connector to disengage a first thread of the connector body from a second thread of the distal end of the injector. As the connector body rotates, the rotating disk may rotate relative to the connector body, thus remaining fixed relative to the reusable injector. Thus, the needle may retract axially from the septum as the connector body rotates. Step 1825 may include removing the modular needle connector from the distal end of the injector.

[0105] Method 1800 may end after step 1825. In other examples, additional steps according to the examples above may be performed. For example, the process may be repeated by repositioning the needle of the modular needle connector proximate the distal end of the injector and piercing the septum with the proximal end of the needle at a second location. As described throughout this disclosure, the second location may differ from the first location of method 1800 because the disk is rotatable and thus the placement of the needle on the septum may be random. Additionally, a step of administering a therapeutic agent through the distal end of the needle may be performed, for example, between steps 1815 and 1820 above.

[0106] The descriptions contained herein are examples of embodiments of the present disclosure and are not intended to limit the scope of the present invention in any manner. As described herein, the present disclosure contemplates many variations and modifications of the suction device, including the use of alternative geometric forms of structural elements, combinations of shapes and structural elements from various exemplary embodiments, the use of alternative materials, etc. These modifications would be apparent to one skilled in the art to which the present disclosure pertains, and are intended to be within the scope of the following claims.

Claims

1. 1. A modular needle connector, comprising: A circular disc, a needle orifice located non-concentrically with respect to the center of the circular disk; a needle disposed within the needle opening, the needle having a distal end extending from a first side of the circular disk and a proximal end extending from a second side of the circular disk; The circular disc comprising: A connector body, a disk slot disposed in a first end of the connector body sized to receive the circular disk; an injector housing disposed at a second end of the connector body and dimensioned to engage a reusable injector; the connector body, Including, The modular needle connector, wherein the proximal end of the needle is disposed within the injector housing when the connector body is engaged with the reusable injector.

2. 2. The modular needle connector of claim 1, wherein a first height and a first diameter of the circular disk are smaller than a second height and a second diameter of the disk slot such that the circular disk is rotatable within the disk slot when the connector body is disconnected from the reusable injector.

3. The modular needle connector of claim 1 , wherein the connector body further comprises a plurality of flexible wings extending along at least a portion of the length of the injector housing.

4. The modular needle connector of claim 3 , wherein an inner surface of the plurality of flexible wings includes threads dimensioned to engage the reusable injector.

5. The modular needle connector of claim 1 , wherein the distal end of the needle comprises a beveled tip and the proximal end of the needle comprises a non-coring tip.

6. The modular needle connector of claim 5 , wherein the non-coring tip includes a blunt tip and a lateral fluid inlet.

7. a reusable injector including a septum; 1. A modular needle connector, comprising: A rotating disk including a needle extending through the rotating disk at a location not concentric with a center of the rotating disk, the needle comprising: a distal end extending from a first side of the rotating disc; a proximal end extending from a second side of the rotating disc; The rotating disk comprising: A connector body, a disk slot disposed in a first end of the connector body and sized to receive the rotating disk; an injector housing disposed at a second end of the connector body and dimensioned to engage the reusable injector; the connector body, the modular needle connector, Including, The system wherein the proximal end of the needle extends into the injector housing and is movable from a first position within the injector housing to a second position within the injector housing by rotation of the rotating disk.

8. The system of claim 7 , wherein the connector body further comprises a plurality of flexible wings dimensioned to engage the reusable injector proximate the septum.

9. The system of claim 8 , wherein an inner surface of the plurality of flexible wings includes a first thread dimensioned to engage a second thread of the reusable injector adjacent the septum.

10. 8. The system of claim 7, wherein an inner surface of the injector housing includes a first thread dimensioned to engage a second thread of the reusable injector adjacent the septum.

11. The system of claim 7 , wherein the distal end of the needle comprises a beveled tip and the proximal end of the needle comprises a non-coring tip.

12. The system of claim 11 , wherein the non-coring tip includes a blunt tip and a lateral fluid inlet.

13. 8. The system of claim 7, wherein a first axis of the rotating disk is coaxial with a second axis of the septum, and the needle is off-axis from the first axis and the second axis.

14. The system of claim 7 , wherein the proximal end of the needle is fixed when inserted into the septum and the rotating disk is fixed when the connector body is seated in the reusable injector.

15. disposing a modular needle connector adjacent a distal end of the injector; piercing a septum of the injector at a first location with a proximal end of a needle in the modular needle connector, the needle being connected to a rotating disk in the modular needle connector; axially advancing the modular needle connector into the distal end of the injector; rotating a connector body of the modular needle connector to disengage first threads of the connector body from second threads of the distal end of the injector, wherein rotating the connector body rotates the rotating disk as the proximal end of the needle is axially withdrawn from the first position; Removing the modular needle connector from the distal end of the injector; A method comprising:

16. piercing the septum at a second location with the proximal end of the needle; rotating the connector body to disengage the first threads from the second threads of the distal end of the injector, where rotating the connector body rotates the rotating disk as the proximal end of the needle is axially withdrawn from the second position; The method of claim 15 further comprising:

17. The method of claim 15 , wherein the needles are positioned non-concentrically with respect to a center of the rotating disk.

18. The method of claim 15 , wherein axially advancing the modular needle connector into the distal end of the injector includes advancing flexible wings over the distal end of the injector.

19. The method of claim 18 , wherein the first thread is disposed on an inner surface of the flexible wing.

20. 16. The method of claim 15, further comprising administering an injection regimen through the distal end of the needle.

21. a reusable injector including a septum; a plurality of attachable needle connectors dimensioned to attach to a distal end of the reusable injector adjacent the septum, a first needle connector including a first needle, a proximal end of the first needle corresponding to a first location on the septum; a second needle connector including a second needle, a proximal end of the second needle corresponding to a second location on the septum; and the plurality of attachable needle connectors, Including, The system wherein the first location and the second location are different locations.

22. A first needle connector; a third needle connector including a third needle, a proximal end of the third needle corresponding to the first location on the septum; and 22. The system of claim 21, further comprising a first set of needle connectors comprising:

23. the distal end of the reusable injector comprises a circular cross-section; a proximal end of each of the plurality of attachable needle connectors is concentrically positionable within the distal end of the reusable injector; the proximal end of the first needle is concentrically disposed with the distal end of the reusable injector; The system of claim 21 , wherein the proximal end of the second needle is non-concentrically disposed with the distal end of the reusable injector.

24. the distal end of the reusable injector includes a first anti-rotation mechanism; 22. The system of claim 21, wherein each of the plurality of attachable needle connectors includes a second anti-rotation feature dimensioned to engage the first anti-rotation feature.

25. the distal end of the reusable injector comprises a circular cross-section; a proximal end of each of the plurality of attachable needle connectors is concentrically positionable within the distal end of the reusable injector; the proximal end of the first needle is offset from the second anti-rotation feature by a first radial offset; the proximal end of the second needle is offset from the second anti-rotation feature by a second radial offset; The system of claim 24 , wherein the first radial offset is different from the second radial offset.

26. the first anti-rotation feature is one of a keyway or a key; 25. The system of claim 24, wherein the second anti-rotation feature is one of a key or a keyway and is the opposite of the first anti-rotation feature.

27. the first anti-rotation feature is a first cross-sectional geometry of the distal end of the reusable injector; the second anti-rotation feature is a second cross-sectional geometry of a proximal end of each of the plurality of attachable needle connectors; 25. The system of claim 24, wherein the first cross-sectional geometry and the second cross-sectional geometry are non-circular.

28. 22. The system of claim 21, wherein the second needle includes a curved portion disposed between the proximal end of the second needle and the distal end of the second needle.

29. A kit including a plurality of needle connectors attachable to a reusable injector, a first set of one or more needle connectors each including a first needle, the proximal end of each first needle being positioned to pierce a first location on a septum of the reusable injector; a second set of one or more needle connectors each including a second needle, the proximal end of each second needle being positioned to pierce a second location on the septum; Including, The kit, wherein the first location and the second location are different locations.

30. 30. The kit of claim 29, wherein the first set includes between two and five needle connectors.

31. 30. The kit of claim 29, wherein the first set consists of five or fewer needle connectors.

32. the first set includes a first needle connector and a second needle connector, the first needle connector indexed for a first injection regimen and the second needle connector indexed for a second injection regimen; 30. The kit of claim 29, wherein the second set includes a third needle connector and a fourth needle connector, the third needle connector indexed for a third injection regimen and the fourth needle connector indexed for a fourth injection regimen.

33. the first set includes the first needle connector; the second set includes the second needle connector; 30. The kit of claim 29, a third needle connector, a fourth needle connector, a fifth needle connector, a sixth needle connector, and a seventh needle connector; The kit, wherein each needle connector is indexed for one of a seven dose injection regimen.

34. 34. The kit of claim 33, wherein the proximal end of each needle connector is positioned to pierce a different location on the septum.

35. each needle connector of the first set includes a first anti-rotation feature dimensioned to correspond to a second anti-rotation feature of the reusable injector; 30. The kit of claim 29, wherein each needle connector of the second set includes a third anti-rotation feature dimensioned to correspond to the second anti-rotation feature of the reusable injector.

36. the first anti-rotation feature and the third anti-rotation feature are one of a keyway or a key; 36. The kit of claim 35, wherein the second anti-rotation feature is one of a key or a keyway and is the opposite of the first anti-rotation feature and the third anti-rotation feature.

37. the first anti-rotation feature and the third anti-rotation feature are first cross-sectional geometries of a proximal end of each of the first and second sets of needle connectors; the second anti-rotation feature is a second cross-sectional geometry of a distal end of the reusable injector; 36. The kit of claim 35, wherein the first cross-sectional geometric shape and the second cross-sectional geometric shape are non-circular.

38. selecting a first needle connector for a first injection regimen; disposing the first needle connector adjacent a distal end of a reusable injector; piercing a septum of the reusable injector at a first location on the septum with a proximal end of a first needle of the first needle connector; administering the first injection regimen to a patient; selecting a second needle connector for a second injection regimen; disposing the second needle connector adjacent the distal end of the reusable injector; piercing the septum at a second location on the septum with a proximal end of a second needle of the second needle connector; administering the second injection regimen to the patient; and Including, The method, wherein the first location and the second location are different locations.

39. 40. The method of claim 38, further comprising rotating the first needle connector to mate a first anti-rotation feature on the first needle connector with a second anti-rotation feature on the reusable injector.

40. selecting a third needle connector for a third injection regimen; disposing the third needle connector proximate the distal end of the reusable injector; piercing the septum at a first location on the septum with a proximal end of a third needle of the third needle connector; administering the third injection regimen to the patient; and 40. The method of claim 38, further comprising:

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