Automatic needle inserter for pen injection system

Abstract

To provide an automatic needle inserter for a pen injector.SOLUTION: The automatic needle inserter has an elongated inserter body dimensioned and configured to receive the pen injector when introduced into a longitudinal bore of elongated inserter body via the proximal extremity thereof. The automatic inserter body is also configured to prevent the pen injection system from exiting the longitudinal bore via the distal extremity of the inserter body. The automatic needle inserter is provided with rotationally-activated locking means to lock the pen injector in an axial position within the longitudinal bore via rotation of at least a part of the elongated inserter body about the central longitudinal axis from a first non-locking position to at least one or more second locking positions.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates generally to accessories for injection pen systems. [Background technology]

[0002] Injection pen systems are well known per se and typically include a proximally located dose setting wheel and an injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system. The wheel is rotated by a user to select a dose of medication to be administered. The pen is typically mechanically or electromechanically configured to initiate an injection upon activation of the injection activator. Such an injection activator is most commonly a simple depressible or push button that is in mechanical or electrical contact with a dispensing mechanism located within the pen injection system, and when depressed, fires the injection mechanism and injects the medication contained within the pen injection system. In some pen injector systems, the dose setting wheel is configured to rotate not only during dose setting but also during injection. This is typically achieved by including one or more metallic components, such as a helically wound drive spring, located within the injection pen system's housing body and physically coupled to the dose setting wheel.

[0003] Injection pen systems of the type described above are used by both medically trained and non-medically trained users. While medically trained users have received appropriate training and are familiar with the operation of such devices, individual non-medically trained users, such as patients themselves, may still struggle to use these devices correctly and / or appropriately. Moreover, manufacturers of such pen injection systems have, over time, attempted to make such systems as easy and reliable to use as possible.

[0004] Despite the above-described advances in pen injection system technology, at least some users remain challenged with properly using such pen injection systems. For example, some users who need to administer medications provided by such injection pen systems have difficulties with nerve and / or muscle coordination, resulting in incomplete, imprecise, or inaccurate operation of the pen injection system. Other users have fears about seeing, handling, or other needle manipulations, including inserting a needle into the body, and thus face significant psychological challenges when attempting to use most commonly available commercial injection pen systems, despite the relative improvements in ease of use. Such challenges can impact patient health and, more importantly, patient compliance with treatment regimens that include such pen injection systems.

[0005] As a result, some attempts have been made to overcome the above difficulties by providing automatic or semi-automatic needle inserters. The purpose of such needle inserter devices, which may be considered both separate devices and accessories in themselves, is to facilitate the presentation of the needle of an injection pen system at the injection site at the correct angle of insertion into the body by allowing the user to identify the position of the pen within the automatic needle inserter, arm the automatic needle inserter so that the injection pen system is ready to inject, and then allow the user to release the armed injection pen system so that the user is freed from having to face the direct sight of having to prick themselves with the needle of the pen injection system.

[0006] For example, U.S. Patent Nos. 5,999,949 and 5,999,952 both relate to an automatic needle insertion device for a pen-type injector, the device comprising a tubular housing in which an injection pen is mounted within a tubular pen holder, the pen holder being axially movable in a proximal direction, i.e., toward the user's hand and / or body, along the longitudinal axis of the pen and automatic needle insertion device, to cock a spring that is subsequently released to drive the pen holder, together with the pen, in a distal direction a set distance. The injection pen is connected to the distal side of a drug-containing cartridge, at the distal end of which a needle is attached. This system is unique to products manufactured and commercialized by the applicant of these patents.

[0007] Furthermore, Patent Document 3 relates to another automatic needle inserter device configured to receive an injection pen system, such as an insulin injection pen, the needle inserter device comprising a body with a holder for the injection system, the body configured to move from an armed position to an unarmed position via actuation of a command member, thereby allowing axial displacement of the holder. The automatic needle inserter body comprises a threaded clamping ring system that allows insertion of the injection pen system into the automatic needle inserter body. The threaded clamping ring system comprises an engagement surface having a proximal frusto-conical inner surface that gradually engages via a threading action of the clamping ring against a correspondingly shaped frusto-conical outer surface of the hollow deformable part, thus compressing the plastic ring and thereby reducing the diameter of the opening from a first, wider diameter position, in which free axial movement of the pen injection system is permitted, to a second, narrower diameter position, in which the plastic ring is pressed against the body of the pen injection system to hold the body.

[0008] As used herein, the terms "pen injection system" and "injection pen system" are used interchangeably to refer to generally handheld pen-type injection systems, which are readily known and commercially available for use in treating many different medical indications. These systems are often generally designed for self-injection of medication by a user in need of treatment for a given medical indication. This is the case, for example, with insulin, which is supplied in various forms for use in treating diabetes. However, it should be noted that similarly configured injection pen systems are also available for or used in the treatment of other physiological and / or pathological conditions using a variety of injectable formulations containing active ingredients such as adrenaline, epinephrine, methotrexate, recombinant monoclonal antibodies, human growth hormone, hyaluronic acid, and the like. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Patent No. 5,980,491 [Patent Document 2] U.S. Patent No. 6,537,252 [Patent Document 3] French Patent Application Publication No. 3079422 Summary of the Invention [Problem to be solved by the invention]

[0010] Accordingly, it is an object of the present invention to provide an automatic needle inserter for pen injection systems that is adapted to receive and function with the various shapes and sizes of injection pen systems currently in use.

[0011] Another object of the present invention is to provide an automatic needle inserter for a pen injection system that is easier to use and handle, safer and more reliable than known solutions.

[0012] These and other objects of the present invention will become readily apparent from a complete reading of this specification. [Means for solving the problem]

[0013] Thus, in accordance with any of the above objects, there is provided an automatic needle inserter adapted and configured for the pen injection system outlined above, the automatic needle inserter comprising: an elongate inserter body having a proximal end and a distal end; and a longitudinal bore extending through the elongate body from the proximal end to the distal end, the longitudinal bore having a central longitudinal axis, the elongate inserter body being sized and configured to receive a pen injection system introduced into the bore through the proximal end of the inserter body and being further configured and dimensioned to prevent the pen injection system from exiting the longitudinal bore through the distal end; The long inserter body is and a rotationally actuated locking means configured to lock the pen injection system in an axial position within the longitudinal bore by rotating at least a portion of the elongated inserter body about the central longitudinal axis from a first unlocked position to at least one or more second locked positions.

[0014] As previously mentioned, the elongate inserter body is sized and configured to receive a pen injection system introduced into the bore through the proximal end of the inserter body. Such configuration assumes that the bore opening at the proximal end of the elongate inserter body is of sufficient size to allow at least the distal end of the pen injection system to be inserted into the opening and longitudinal bore. The general overall shape of the elongate inserter body is cylindrical, although it is also possible to provide an appropriate size, shape, and configuration of the bore expanding and / or contracting along the length of the inserter body depending on the shape of the pen injection system.

[0015] Additionally, the elongate inserter body is suitably configured and dimensioned to prevent the pen injection system from exiting the longitudinal bore through the distal end of the inserter body. This can be achieved in a variety of ways, for example, by providing one or more abutment shoulders projecting inward from the interior surface of the elongate inserter body, or other forms of suitable abutments that prevent over-insertion of the pen injection system along the axial length of the inserter body. Particularly advantageous solutions are provided in more detail elsewhere herein.

[0016] As previously mentioned, the elongated inserter body further comprises a rotationally actuated locking means configured to lock the pen injection system in an axial position within the longitudinal bore by rotation of at least a portion of the elongated inserter body about the central longitudinal axis from a first unlocked position to at least one or more second locked positions. As can be seen from the preceding text, the elongated inserter body is provided with means for rotationally locking the pen injection system in a predetermined axial position within the bore along the length of the elongated inserter body bore. Such rotational locking of the pen injection system against axial movement along the length of the bore is achieved by rotation of a portion of the elongated inserter body itself, in contrast to solutions provided in the prior art that use an additional threaded ring attached to the outside of the proximal end of what is considered the elongated inserter body. The functional difference between the prior art solution known from U.S. Patent No. 5,629,999 and the proposed solution of the present invention is clear. While both solutions involve rotation to achieve locking of the injection pen, the currently proposed solution operates in a much simpler and more user-friendly manner, involving rotation of a portion of the elongated inserter body itself, rather than an additional element to be manipulated. In this respect, the solution proposed according to the present invention functions in a manner similar to a pepper grinder, with a part of the elongated inserter body itself rotating in a first direction about its longitudinal axis to operate the pen lock and then rotating in the opposite direction after the injection to release the injection pen from the elongated inserter body.

[0017] Additionally, the configuration contemplated by this object also provides a rotational movement from a first, unlocked position to at least one or more second locked positions. The at least one or more second locked positions are configured to correspond to the major diameters of currently used injection pens. As a result, users of automatic needle inserters according to the present invention are provided with a highly user-friendly, reliable, and functional solution that eliminates the guesswork involved in prior art solutions, which involve users having to determine whether the threaded clamping ring is properly tightened to the appropriate extent or whether the threads are overtightened, potentially causing failure of one or more components. Insufficient threading risks prior art injection pen systems being pulled out of the inserter body, forcing the user to start over, or, even worse, catastrophically damaging the inserter device and causing the pen to suddenly withdraw from the inserted device, potentially exposing the injection needle to undesirable accidental contact with the user. Furthermore, the object described and provided herein avoids some of the other drawbacks of the prior art discussed above, particularly the requirement in prior art solutions to provide as many different clamping rings as there are injection pen diameters. Furthermore, the prior art solution described in US Patent No. 5,999,949 increases the risk of failure of the injection pen because the inserter device described therein may physically lock and interfere with some of the mechanically moving parts of the injection pen. This is in stark contrast to the objectives described and presented herein, which are configured to avoid physical locking contact with moving parts of the pen injection system, instead interacting with and abutting non-deforming parts of the injection pen system, such as, for example, the outer surface of the pen cartridge holder and / or the outer surface of the medication cartridge, thereby avoiding the risk of changing the selection and / or injection mechanism of the injection pen system.

[0018] According to another object, an elongated inserter body includes at least a first elongated outer body component and at least a second elongated outer body component, wherein at least one of the at least first elongated outer body component and the at least second elongated outer body component is configured to rotate about a central longitudinal axis relative to the at least other elongated outer body component during locking. In this configuration, the elongated inserter body preferably has two outer body components, for example, a substantially proximally positioned elongated outer body component extending from the proximal end of the inserter body to the distal end and a substantially distally positioned elongated outer body component extending from the distal end of the inserter body to the proximal end, the two outer body components rotatably meeting and interconnecting each other at appropriate points along the longitudinal axis. Preferably, such a configuration provides a proximal outer body component that extends toward the distal end of the inserter body over a distance greater than the proximal extension of the corresponding distally positioned outer body component. Thus, in such a configuration, the proximal outer body is longer than the distal outer body.

[0019] Thus, in yet a further object, an elongate inserter body includes at least a first elongate outer body component and at least a second elongate outer body component, the at least first and at least second elongate outer body components configured to rotate relative to one another in opposite directions about a central longitudinal axis during locking. In accordance with such object, the elongate inserter body functions in a manner similar to a pepper grinder, for example, where a user holds each outer body component in a separate hand and then rotates one outer body component relative to the other, or rotates both outer body components in opposite directions about the central longitudinal axis from a first position to one or more second positions.

[0020] As used herein, references to "outer" with respect to elongate bodies mean that those body components are radially outermost with respect to the central longitudinal axis when considering the automatic inserter device as a whole. Consequently, any elements referred to as "internal," "inner," or "inward-facing" refer to the portion of the device that is contained within or located within or oriented generally inwardly into the bore formed by that outer body component.

[0021] According to another object, the rotationally actuated locking means comprises a compression ring having a nominal thickness and a nominal inner diameter defining a central bore, the compression ring being positioned coaxially within the longitudinal bore of an elongate inserter body. The compression ring is coaxially positioned within the bore of the elongate body, and when the elongate body comprises a proximal outer body component and a distal outer body component, the compression ring is preferably completely covered and surrounded by the proximal outer body component such that the inward-facing surface of the proximal outer body component contacts the outward-facing surface of the compression ring. In such a configuration, the outward-facing surface of the compression ring is shaped and configured to engage the inward-facing surface of the proximal outer body component such that any rotation about the central longitudinal axis of the proximal outer body component is transmitted to the compression ring, causing it to rotate to the same degree or angle of rotation about the central longitudinal axis as the proximal outer body component. To achieve this function, for example, the outward-facing surface of the compression ring can be provided with one or more radially spaced ridges projecting from the outward-facing surface of the compression ring, which mate with corresponding, appropriately shaped and configured complementary recesses on the inward-facing surface of the proximal outer body component, the recesses being located at or near the distal end of the proximal outer body component. Similarly, and alternatively, means for achieving the same or similar functional result can be envisioned, such as a suitable protruding spigot extending inward from the inward-facing surface of the outer body component into the bore of the elongate outer body, which mates with a correspondingly shaped, complementary groove, notch, or recess on the outward-facing surface of the compression ring, such that when the proximal outer body component is rotated, the protruding spigot engages with a corresponding, complementary configured groove, notch, or recess on the outward-facing surface of the compression ring, thereby driving the compression ring to rotate about its central longitudinal axis.

[0022] According to yet another object, the compression ring has a variable inner diameter relative to a nominal inner diameter. By "variable inner diameter," it is to be understood that the compression ring does not have a constant inner diameter throughout the compression ring bore, for example, due to the shape of the inwardly facing surface or due to a corresponding change in the thickness of the compression ring extending inwardly into the compression ring bore.

[0023] According to yet another object, the compression ring comprises at least one portion having an increased inner diameter relative to the nominal inner diameter.

[0024] According to yet another object, the compression ring comprises at least one portion having an inner diameter that is reduced relative to the nominal diameter.

[0025] According to yet another object, at least one portion of the compression ring having an increased inner diameter extends around the circumference of the inner diameter of the compression ring with the inner diameter gradually decreasing toward the portion of the compression ring having the decreased inner diameter. This may be understood to mean that the inner diameter is gradually changed around the circumference of the inner diameter of the compression ring, e.g., essentially transitioning from a portion of the compression ring having a diameter larger than the nominal inner diameter, passing through the nominal inner diameter at some point along the circumference, and then terminating with another portion of the compression ring having an inner diameter smaller than the nominal inner diameter. Such a transition may be effected, for example, by appropriately varying the radius of curvature of the circumference of the inner diameter.

[0026] In accordance with yet another object, the general concept described above for a variable inner diameter can be suitably provided, wherein the compression ring includes at least one portion extending inwardly into the central bore and having an increased thickness relative to the nominal thickness of the ring.

[0027] According to yet another object, in a complementary manner to the preceding paragraph, the compression ring comprises at least one portion extending inwardly into the central bore and having a reduced thickness relative to the nominal thickness of the ring.

[0028] According to yet another object, at least one portion of the compression ring having an increased thickness extends circumferentially inward from the outer periphery of the compression ring into the central bore of the compression ring, with the thickness gradually decreasing toward the portion of the compression ring having a decreased thickness.

[0029] According to yet another object, the rotationally actuated locking means further comprises a compressible membrane of elastic material, which is provided as a contact surface for the inwardly facing surface of the compression ring. The elastic material of the compressible membrane is suitably selected from a range of available materials, such as elastomers, e.g., elastomers based on thermoplastic polymers, such as styrene-ethylene-butylene-styrene copolymers, commonly referred to as SEBS elastomers. Such elastomers behave similarly to rubber without the need for vulcanization, and most such SEBS elastomers are generally obtained by selective hydrogenation of styrene-butadiene-styrene copolymers.

[0030] According to yet another object, a compressible membrane of elastic material is coaxially positioned within the bore of a generally ring-shaped compression ring with its own bore.

[0031] Furthermore, according to yet another object, the compressible membrane is compressed from a relaxed state to a compressed state by rotational movement of the compression ring about the central longitudinal axis from a first unlocked position to one or more second locked positions.

[0032] Thus, the variable inner diameter of the compression ring, as expressed in various objects above, is used to provide both variability and control over the degree of engaging contact between the inwardly facing surface of the compression ring and the outwardly facing surface of the compressible membrane. In this way, rotation of the compression ring with its variable inner diameter causes the inwardly facing surface of the compression ring to increase in surface compressive contact with the outwardly facing surface of the compressible membrane, thereby causing the compressible membrane to contract and compress around any object that happens to be located within the pores of the compressible membrane.

[0033] Thus, according to yet another object, the inwardly facing surface of the compressible membrane is brought into contact with the outer surface of the body of the pen injection system by rotational movement of the compression ring about the central longitudinal axis from a first unlocked position to one or more second locked positions.

[0034] As can be seen from the above and as contemplated herein, the restriction and compression of the compressible membrane as the compression ring is rotated about its central longitudinal axis in conjunction with the change in the inner diameter of the compression ring abutting the compressible membrane causes the inner surface of the compressible membrane to compress and contract onto the outer surface of the body of an injection pen system inserted into the elongated body of an automatic needle inserter. When the compression ring is rotated from a first unlocked position, in which the pen injection system still has some freedom of movement about the central longitudinal axis within the bore of the outer elongated body, to a second locked position, the compression ring rotates with the outer elongated body, and the inner surface of the compression ring engages the outer surface of the compressible membrane, causing compression and contraction of the compressible membrane around the body of the pen injection system, thereby locking the pen injection system in place. The one or more second positions contemplated for purposes herein are related to and indexed by the relative outer diameters of major types of pen injection systems currently available. Thus, the device can accommodate future alternative pen diameters and can be configured to lock with various configurations of currently contemplated needle inserter devices.

[0035] According to yet another object, the first unlocked position and one or more second locked positions may be provided with corresponding visual or audible indicators, thereby allowing a user to know when a particular position has been reached. Such visual or audible indicators may be beneficially provided, for example, by visual markings located on corresponding associated portions of the elongate outer body, for example, at the junction where the proximal and distal outer body components meet. Such visual markings may be represented, for example, by notches in the outward-facing surfaces of one or more outer body components, optionally supplemented by numbers or letters etched to indicate each expected position. If audible indicators are implemented, these may be provided by audible engagement of corresponding surfaces of the first and second elongate outer body components, producing, for example, an audible click when the first surface of one outer component comes into seating or positioning contact with the second elongate outer body component. Generally, such audible indicator markers may comprise a protrusion extending from the inward-facing surface of one of the outer body components and a corresponding groove or complementary recess on the other outer body component, whereby an audible sound is generated by friction of one of the two surfaces against the other when the protrusion and recess contact one another, when the protrusion fits into the groove, and / or vice versa. For example, as envisioned by one purpose of the present device, a series of successively increasing numbers or letters, e.g., letters A through E or numbers 0 through 4, may be provided on the exterior surface of one of the outer body components, each number or letter representing a position corresponding to a predetermined rotation of one of the outer body components about the central longitudinal axis, each rotational position corresponding to a required degree of compression sufficient to maintain and retain the body of the pen injection system within the bore by action of a compression ring on the compressible membrane, and corresponding to a predetermined outer diameter of the pen injection system body.

[0036] Furthermore, to facilitate visualization by the user of the relative indexed unlocked and locked positions, respectively, an outer body component not provided with such markings may be beneficially provided with a magnifying surface, e.g., via a convex or magnifying lens, extending therefrom over the area of ​​the outwardly facing surface of the other outer body component on which the markings are provided. When the outer body component is moved to the corresponding unlocked or locked position, the appropriately indexed magnifying surface is positioned over the visual markings provided on the other outer body component, thereby magnifying the markings via the magnifying surface, resulting in a position marker that is readily visible to the user.

[0037] According to yet another object, the compression ring is attached or mounted to a slidable carriage assembly configured to translate the compression ring along a central longitudinal axis from an unloaded position to an armed position. The purpose of such a slidable carriage is to provide an automatic insertion function for the needle inserter. Thus, the slidable carriage assembly is configured to be movable along the central longitudinal axis from a first unloaded position, in which injection is not possible and no injection is being performed, to a second armed position, typically proximal to the unloaded position, in which the pen injection system is primed for release at any time for subsequent movement in a direction opposite the armed direction, typically distal.

[0038] According to yet another object, the slidable carriage assembly includes a bore coaxially aligned with the bore of the compression ring, the slidable carriage assembly and the compression ring mounted or attached thereto thereby forming a single slidable member having a common longitudinal bore.

[0039] According to yet another object, at least a portion of the slidable carriage assembly is configured to co-rotate about a central longitudinal axis with the compression ring, particularly during rotational movement of the elongated outer body from a first unlocked position to one or more second locked positions. In other words, the slidable carriage assembly is shaped and dimensioned to receive the compression ring such that the compression ring can rotate about the central longitudinal axis during locked and corresponding unlocked rotations of an injection pen system inserted within the bore of the elongated body. Thus, the portion of the slidable carriage assembly configured to co-rotate with the compression ring comprises an elongated substantially cylindrical body with a bore coaxially aligned with the compression ring. One way to accomplish this is to provide a single rotatable molded cylinder that combines both the rotatable compression ring portion and the rotatable portion of the slidable carriage assembly. Alternatively, the compression ring and the rotatable portion of the slidable assembly may be attached together, e.g., via suitably shaped and configured resiliently deformable clips or hooks on either the compression ring or the rotatable portion of the slidable assembly, and correspondingly shaped and configured recesses to engage such clips in their resiliently deformed state, such that rotation of one body, e.g., the compression ring, causes a corresponding and equal rotation of the other body, i.e., the rotatable portion of the slidable carriage assembly, in the same rotational direction about the central longitudinal axis.

[0040] According to another aspect, a slidable carriage assembly extends from a compression ring in both a proximal and a distal direction along a central longitudinal axis. The proximally extending portion of the slidable carriage assembly is the rotatable portion described above with respect to the compression ring. Thus, the slidable carriage assembly can be considered an assembly of a proximal portion and a distal portion, with the compression ring positioned between the proximal and distal portions. In such a configuration, the first proximal portion has a cylindrically shaped body with a central longitudinal bore as described above and co-rotates with the compression ring. The proximal portion also includes a distal end, e.g., having an inwardly facing annular groove. The annular groove is suitably configured and dimensioned to receive two or more radially spaced protruding arcuate walls that extend proximally from a second distal portion of the slidable carriage assembly and terminate in a radially outwardly protruding spur or hook portion. During assembly of the device, the protruding arcuate wall of the second distal portion of the carriage body is inserted through the aperture in the compression ring and into the coaxially aligned aperture in the first proximal, rotatable portion of the slidable carriage assembly, such that the outwardly protruding spur or hook on the proximal end of the arcuate wall engages the annular groove in the first proximal portion of the slidable carriage assembly. The arcuate wall and the outwardly protruding hook portion on its proximal end engage the annular groove in a non-rotationally inhibiting engagement, i.e., the protruding hook portion is free to move clockwise or counterclockwise along the groove when the compression ring and first proximal portion of the slidable carriage assembly are rotated in corresponding clockwise or counterclockwise directions about the central longitudinal axis.

[0041] The second distal portion of the slidable carriage assembly further includes a radially outwardly projecting ridge that forms a proximally facing distal abutment surface for the distal end of the compression ring. Because the first proximal rotatable portion and the second distal portion of the carriage body are maintained axially spaced apart relative to one another, the compression ring is captured against independent axial movement along the longitudinal axis. This is even more true when the compression ring and the proximal rotatable portion of the slidable carriage assembly are comprised of a single molded cylindrical body. The projecting arcuate wall of the second distal portion of the carriage body advantageously provides a convex, curved, outwardly facing surface against which the compression ring can rotate during position locking and unlocking of the injection pen body. Another advantageous feature of the radially spaced, protruding arcuate walls extending from the second distal portion of the slidable carriage assembly is that the spaces between the extending arcuate walls are dimensioned to receive and retain, under lateral compression, corresponding radially outwardly extending protrusions of compressible elastic membrane material. Such radially outwardly extending protrusions of compressible elastic membrane material correspond to outwardly facing contact surfaces that contact the compression ring during rotation of the compression ring and appropriately transmit the compressive force gradually applied by the compression ring to compress the membrane and reduce the diameter of the compressible membrane aperture on the body of the pen injection system. The compressible membrane may suitably be provided with two or more, e.g., four, six, or eight, radially spaced, outwardly extending protrusions of compressible material. In one particularly advantageous embodiment, the compressible material may be molded as a cylinder on the inwardly facing surface of the arcuate walls with corresponding longitudinal apertures coaxially aligned with the central aperture.

[0042] As can be seen, when the slidable carriage assembly moves axially, whether in the proximal or distal direction, the compression ring is forced to move axially by the same amount and translate with the carriage assembly.

[0043] According to yet another object, the slidable carriage assembly and the compression ring each include surface engagement means configured to engage in sliding engagement with the first elongate outer body component to permit translation of the compression ring, along with the slidable carriage assembly, from an unloaded position to a loaded position without rotation of either the compression ring or the slidable carriage assembly within the bore of the first elongate outer body component. Such surface engagement means, which are generally complementary to one another, may be suitably provided in a number of ways.

[0044] For example, according to another object, the surface engaging means of the slidable carriage assembly comprises at least one protruding contact member extending radially outward from the slidable carriage assembly.

[0045] According to another object, at least one protruding contact member extending radially outward from the slidable carriage assembly engages in axial sliding contact with at least one corresponding runnel provided on the first elongate outer body component. The at least one corresponding runnel envisioned herein extends parallel to the longitudinal axis along at least a portion of the inward-facing surface of the first outer body component. The runnel receiving the protruding contact member of the slidable carriage assembly surrounds the protruding contact member and prevents rotation of the carriage assembly about the central longitudinal axis as the carriage assembly moves from the unloaded position to the loaded position.

[0046] According to another object, the at least one protruding contact member extending radially outward from the slidable carriage assembly also extends proximally beyond the proximal end of the proximal portion of the slidable carriage assembly. As can be seen, the at least one radially outwardly protruding contact member may be suitably represented, for example, as a series of radially spaced, outwardly protruding legs located on an outward-facing surface of the first proximal portion of the slidable carriage assembly and extending further along the first proximal portion of the carriage assembly parallel to the central longitudinal axis beyond the proximal end of the first proximal portion of the carriage assembly. The length of the protruding legs extending beyond the proximal end of the carriage body is configured, for example, to provide a suitable abutment distance between the proximal end of the carriage body and the proximal end of the outer elongate body, or alternatively, to provide a proximal engagement surface for a biasing element, such as a compression spring, positioned within a bore in the proximal end of the outer body, further limiting the proximal travel distance of the carriage body.

[0047] Similar to the protruding contact members on the slidable carriage assembly, in accordance with yet another aspect, the compression ring includes at least one protruding contact member extending radially outward therefrom. As previously described when describing the compression ring in connection with the proximal outer body component, the outward-facing surface of the compression ring may include one or more radially spaced ridges projecting from the outward-facing surface of the compression ring. These ridges engage corresponding, appropriately shaped and configured, complementary radially spaced recesses or runnels on the inward-facing surface of the proximal outer body component, the recesses or runnels extending along the inward-facing surface of the proximal outer body component parallel to the longitudinal central axis from the distal end to the proximal end of the proximal outer body component.

[0048] According to yet another object, at least one protruding contact member extending radially outward from the compression ring engages in axial sliding contact with at least one corresponding runnel on the first elongate outer body component.

[0049] In accordance with another object, the slidable carriage assembly includes at least one slider arm extending distally from a distal portion of the carriage assembly radially spaced from and parallel to the central longitudinal axis. While it is possible to configure an automated needle inserter according to this disclosure with only one such slider arm, it has been found useful to provide two or more such slider arms extending from the distal end of the carriage assembly to stabilize translational movement of the slidable carriage assembly along the longitudinal axis, with such arms generally positioned radially equidistant about the central longitudinal axis. The slider arms preferably extend distally from a radially protruding ridge on a second distal portion of the slidable carriage assembly and are positioned substantially opposite one another radially spaced about the central longitudinal axis. Additionally, the slider arms are advantageously positioned angularly opposite radially spaced arcuate walls extending proximally from the second distal portion of the carriage body. In other words, considering a clock face on which the slider arms and arcuate walls are disposed, the slider arms would be positioned at the 12 o'clock and 6 o'clock positions, respectively, extending forward from the clock face, and the arcuate walls would be positioned at the 3 o'clock and 9 o'clock positions, extending rearward around the clock face. When more than two pairs of arcuate walls are provided on the second distal portion of the slidable carriage assembly, the distally extending slider arms may be suitably positioned at any angular or clock position between any of these pairs of proximally extending arcuate walls.

[0050] According to another object, at least one slider arm engages in axial sliding contact with at least one corresponding runnel on the second elongate outer body component, the corresponding one or more runnels on the second elongate outer body component extending from a proximal end of the second elongate outer body component toward a distal end of the second elongate outer body component and suitably disposed on an interior-facing surface of the second outer body component. The one or more slider arms slidably engage within the correspondingly positioned one or more runnels, thereby permitting sliding or translational movement of the carriage assembly in both proximal and distal directions while simultaneously preventing rotation of the second outer body component about its central longitudinal axis. The sliding or translational movement of the carriage assembly in the distal direction along the longitudinal axis is limited by the length of the slider arms and corresponding runnels, the distal ends of which form abutment stops with the distal ends of corresponding runnels provided on the second outer body component.

[0051] According to another object, the at least one slider arm has a length sufficient to extend distally into and maintain sliding engagement contact with a corresponding runnel on the second elongate outer body component when the slidable carriage assembly is in the stowed position.

[0052] According to yet another object, the slidable carriage assembly further comprises a releasable trigger means having a trigger member configured to hold the slidable carriage assembly in the armed position until the trigger member is released. The releasable trigger member is provided to allow a user to move the pen injection system distally from the armed position to an injection position where the needle of the pen injection system penetrates an injection surface, such as the skin, to the correct and / or desired penetration depth. Typically, a biasing element, such as a compression spring, provides the impetus for moving the pen injection system from the armed position to the unarmed position via an injection operation. As envisioned herein, the slidable carriage assembly is moved to the armed position by a user of the inserter device, for example, pulling or applying a traction force in a proximal direction on the pen injection system held within the slidable carriage assembly by the compression ring and compressible membrane after the compression ring has been rotated to the locked position. Essentially, the user of the automatic needle inserter pulls the pen body proximally backward against the biasing element, forcing the biasing element against the proximal end of the inserter body, until the trigger member of the releasable trigger is locked and set to the armed position.

[0053] Thus, in accordance with yet another object, the trigger member comprises a resiliently deformable arm movable from a first longitudinal alignment plane in the unloaded position to a second longitudinal alignment plane in the loaded position. The resiliently deformable arm may preferably extend proximally from a proximal portion of the slidable carriage assembly, such that it extends directly along the longitudinal axis from the proximal portion of the slidable carriage assembly, or alternatively, it may extend transversely to the central longitudinal axis and free-floatingly from a tip of a protruding spar that extends perpendicularly from an outer surface of the proximal portion of the slidable carriage assembly and aligns the resiliently deformable arm with the central longitudinal axis. In an undeformed, unloaded state, the resiliently deformable arm lies along a first longitudinal plane that is parallel to the central longitudinal axis. As the slidable carriage assembly is moved proximally, the resiliently deformable arm contacts an abutment, such as a sloped shoulder, on an interior-facing surface adjacent the proximal end of the elongate outer body. The abutment, which is in the same longitudinal plane as the resiliently deformable arm, deforms and moves the arm from a first longitudinal plane into a second longitudinal plane radially spaced from the first longitudinal plane. As the arm is moved proximally by proximal movement of the slidable carriage assembly, the arm deflects or comes into deforming contact with the sloped shoulder of the first outer body component. The arm is deformed from the first plane to the second plane until the proximal end of the arm, e.g., a hook-shaped portion, passes through the shoulder and a corresponding inversely shaped hook portion on the interior surface of the proximal outer body. The hooks of the arms then engage corresponding inversely shaped hooks on the shoulders, causing the trigger member to lock the slidable carriage assembly in a stowed position in the second longitudinal plane in which the hooks of the arms are subject to continued mechanical deformation restraint.

[0054] According to yet another object, the first elongate outer body component includes a release button configured to release the trigger member from the armed position by moving the resiliently deformable arm from the second longitudinal alignment plane to the first longitudinal alignment plane.

[0055] As previously mentioned, one way to achieve this functionality is to provide the trigger member with a latch or hook that engages with a release button on the elongated outer body and maintains the trigger member arm under mechanical constraint in the second longitudinal plane until the release button is activated, for example, by a user pressing the release button. Because the resiliently deformable arm in the armed position was under elastic mechanical constraint imposed by movement from the first plane to the second plane, when the release button is activated, the resiliently deformable arm is released from such elastic constraint and once again assumes its normal position in the first longitudinal plane. In doing so, the carriage assembly is free to move distally by the energy stored in the compression spring, accelerating the carriage assembly and accordingly holding the injection pen to move the injection needle to the correct insertion depth.

[0056] According to another object, the automatic needle inserter comprises a selectively actuatable pen distal end abutment means configured to abut the distal end of an injection pen system upon insertion of the pen injection system into the longitudinal bore of the elongate inserter body along the central longitudinal axis of the longitudinal bore. As used herein, the term "selectively actuatable" should be understood to mean that the pen distal end abutment means functions to abut the distal end of the pen injection system along the central longitudinal axis when introduced into the elongate inserter body in a selectively actuated manner, i.e., by intentional user action on the elongate inserter body or by interaction with the abutment means. In other words, the abutment means is not an element or object forming part of the inserter body that is permanently actuated or that always acts against any introduced injection pen system, but rather can be activated or deactivated as needed. Generally, the pen distal end abutment means is activated prior to introducing the pen injection system into the elongate body of the inserter and is deactivated after the injection pen body is locked in the second, locked position by rotation of a portion of the elongate outer body from the unlocked position to the locked position as described elsewhere herein.

[0057] Therefore, in accordance with yet another object, locking by rotational actuation of the pen injection system occurs only after abutment of the pen injection system by selective operation of the pen distal end abutment means.

[0058] According to yet another object, the selectively actuatable pen distal end abutment means is movable from a first, non-engaged position to a second, engaged position. Such movement can be imparted by, for example, a user's finger or thumb movement, or a combination of finger and thumb movements. Similarly, the pen distal end abutment means is selectively operable in the reverse or opposite direction from the second engaged position to the first, non-engaged position. In this manner, the pen distal end abutment means is configured such that the abutment means can be repositioned to the non-engaged position once the pen injection system is locked in place.

[0059] According to yet another object, the selectively actuable pen distal end abutment means is located adjacent or adjacent to the distal end of the elongate inserter body so that abutment occurs as close as possible to the distal end of the pen injection system, and more particularly, as close as possible to a needle mounting shoulder typically located at the distal end of such an injection pen to which an injection needle is attached, for example by threaded engagement with the needle mounting portion. In this way, when actuated, the pen distal end abutment means interacts with a portion of the injection pen system that defines the needle penetration depth into the injection site, e.g., the patient's skin, when the injection pen is released from the armed position and moved toward the unarmed position under the impact of a biasing element, such as a compression spring. This penetration depth can therefore be controlled and predetermined in advance because the length of injection needles attached to such needle mounting portions is typically standardized and the abutment portion of the needle mounting portion of the pen injection system is located a known, predetermined axial distance from the future injection site before arming the inserter device.

[0060] According to yet another object, the selectively actuatable pen distal end abutment means comprises an articulated arm member configured to rotate about an axis of rotation in parallel alignment with the central longitudinal axis, the articulated arm member being rotatable about the parallel axis of rotation from a first non-abutting position to a second abutting position. According to such object, the articulated arm member may be suitably mounted on an axis of rotation located parallel to the central longitudinal axis and rotatable about the parallel mounting axis such that the arm is movable, e.g., by rotation through interaction of a finger or thumb with the arm, to move the arm from a non-abutting engagement, e.g., essentially flush with the elongated outer inserter body, to an abutting position in which the arm protrudes into a bore in the elongated outer inserter body.

[0061] Thus, according to a further object, the articulated arm member lies flush with the elongate inserter body in the first, non-butting position and extends into the longitudinal bore in the second, abutting position.

[0062] Such a selectively operable and rotatable arm configuration may suitably be provided by a lever arm. For example, the lever arm may have a first graspable end that lies substantially flush with the outward-facing surface of the elongate inserter body in the non-engaged position and a second abutting end that lies essentially flush with the inward-facing surface of the elongate outer inserter body in the non-engaged position. For example, a lifting motion applied by a user to the first graspable end of the lever arm causes the lever arm to rotate about the longitudinal axis of rotation to which the arm is attached and moves the second end of the lever arm from a position essentially flush with the inward-facing surface of the elongate outer inserter body into the bore of the elongate inserter body. In order to maintain the lever arm in either the non-abutting position or the abutting position, the lever arm may further comprise at least one positioning nodule, for example extending perpendicularly outward from the plane in which the lever arm lies on the inserter body and suitably positioned on the lever arm, whereby the at least one positioning nodule fits into at least one corresponding positioning recess provided in the elongated inserter body, thereby determining the angle of movement of the lever arm around the rotation axis and thus the degree to which the second end of the lever arm is moved into the bore of the elongated inserter body.

[0063] These and other objects of the present invention will become apparent and will be explained in more detail in the following description of the drawings and exemplary monitoring module.

[0064] The present invention will now be described in more detail with reference to the accompanying drawings, which are provided for purposes of illustration and example, in which: [Brief explanation of the drawings]

[0065] [Figure 1] 1 is a schematic exploded perspective view of an automatic needle insertion device according to the present invention. [Figure 2A] 2 is a schematic perspective view of the automatic needle insertion device according to FIG. 1 in the unequipped position. [Figure 2B] 2 is a schematic cross-sectional view of the automatic needle insertion device according to FIG. 1 in the unequipped position. [Figure 3A] 2 is a schematic perspective view of the automatic needle insertion device according to FIG. 1 in an armed position ready for injection; FIG. [Figure 3B] 2 is a schematic cross-sectional view of the automatic needle insertion device according to FIG. 1 in an armed position ready for injection. [Figure 4A] 2 is a schematic exploded perspective view of a detail of the automatic needle insertion device according to FIG. 1; FIG. [Figure 4B] 2 is a schematic perspective assembly view of a detail of the automatic needle insertion device according to FIG. 1; FIG. [Figure 5A] 2 is a schematic cross-sectional view of another detail of the automatic needle insertion device according to FIG. 1; FIG. [Figure 5B] 2 is a schematic cross-sectional view of another detail of the automatic needle insertion device according to FIG. 1; FIG. DETAILED DESCRIPTION OF THE INVENTION

[0066] 1 shows a schematic exploded perspective view of an automatic needle inserter device 1 according to the present invention. The automatic needle inserter 1 comprises elongate inserter bodies 2a, 2b having proximal and distal ends 3, 4, and a longitudinal bore 5 extending through the elongate bodies 2a, 2b from the proximal end 3 to the distal end 4, the longitudinal bore 5 having a central longitudinal axis 6, the elongate inserter bodies 2a, 2b being sized and configured to receive a pen injection system 7 introduced into the bore 5 via the proximal end 3 of the inserter bodies 2a, 2b. The elongated inserter bodies (2a, 2b) further comprise rotationally actuated locking means, described in more detail herein, configured to lock the pen injection system (7) in an axial position within the longitudinal bore (5) by rotating at least a portion of the elongated inserter bodies (2a, 2b) about the central longitudinal axis (6) from a first unlocked position (8), marked with a dot (·), to at least one or more second locked positions, marked with a series of visual markers (A, B, C, D, E). Each visual marker corresponds to one of the second locked positions, and more particularly, represents a rotationally locked position for an injection pen system having a predetermined outer diameter of the injection pen body. Essentially, each visual marker corresponds to an angle of rotation about the central longitudinal axis, e.g., set at 15° increments for each rotationally locked position. The proximal end (4) of the elongated inserter body is closed by a closure cap (9) having an annular shoulder (10) extending inwardly from a peripheral annular wall (11) into the bore (5) and defining an opening (12) through which the pen injection system (7) is introduced into the inserter body (2a, 2b). The peripheral annular wall (11) extends distally from the annular shoulder (10) and includes at least one resilient engaging clip, latch, or hook (13) for engaging in a resilient clip engagement with a corresponding recess (14) or lip on the elongated body (2a), the peripheral annular wall (11) being dimensioned to permit insertion thereof into the bore (5). The cap (9) also includes a release button (15) that allows a user to actuate the release of the inserter device to introduce the pen injection needle into an injection site, e.g., a patient's skin, the function of which is described in more detail below.

[0067] As can be seen in Figure 1, the elongate inserter body (2a, 2b) comprises two components: a first proximal outer body component (2b) and a second distal outer body component (2b). The first and second outer body components (2a, 2b) are coupled to one another at their respective distal and proximal ends (16, 17), e.g., as shown. Protruding, resiliently engaging teeth (18) or hooks extend from the proximal end of the second outer body component (2b), and a corresponding annular lip or groove (19) is provided on the distal end (16) of the first outer body component (2a). The resiliently engaging teeth (18) engage the annular groove (19), allowing either or both of the first and second outer body components (2a, 2b) to rotate relative to one another about the central longitudinal axis (6). The second body component (2b) is further provided with a rotational position identification aid (20), such as a magnifying lens, to assist in determining the rotated position of the first and second body components (2a, 2b) relative to one another.

[0068] Also shown in FIG. 1 is a compression spring (21) that is introduced into bore (5) and seated at the proximal end (3) of elongated outer body (2a) and at least partially located within cap (9) and serves to provide an energy storage device for releasing energy after compression when injection pen (7) is released from its armed position within the inserter to introduce an injection needle into the injection site and return automatic needle inserter device (1) and correspondingly hold injection pen (7) in its unarmed position, as described in more detail below.

[0069] The distal end (4) of the second outer body component (2b) is further shaped to resemble the outlet end of a trumpet and, therefore, includes an outwardly projecting annular shoulder or skirt (22) that extends radially outward from the outer surface of the second outer body component (2b). The skirt thereby provides a stable positioning surface suitable for positioning the automatic needle inserter at a patient's or user's injection site. Additionally, a pen distal end abutment means in the form of a lever arm (23) is located at the distal end (4) of the second outer body component (2b), the lever arm including a first graspable end (24) and a second abutment end (25), which are described in more detail below.

[0070] Finally, FIG. 1 also shows further details of the locking and arming system of the automated needle inserter, represented by the compression ring (26) and slidable carriage assembly (27), the details of which will be provided with reference to other figures.

[0071] Figures 2A and 2B respectively show two similar but slightly different views of the automatic needle inserter device according to Figure 1. Figure 2A is a schematic perspective view showing the injection pen system 7 introduced into the bore of the elongated inserter body 2a, 2b through the opening 12 in the closure cap 9 and in the unloaded position, i.e., not positioned for automatic insertion of the needle of the injection pen system 7. The injection pen system 7 shown here, like many other similar pens currently on the market, includes a dose setting wheel 28, a dose visualization window 29, and an injection activation button 30, all of which are visible and accessible to the user and protrude outside the elongated inserter body 2a, 2b through the opening 12 in the cap 9 beyond the proximal end 3 of the proximal body component 2a. A release button 15 is also visible at the proximal end 4 of the elongated inserter body 2a, 2b. The proximal and distal outer body components 2a and 2b are connected to each other at their respective distal and proximal ends 17 and 17, respectively, to form an elongated cylindrical body that surrounds and receives most of the body 31 of the injection pen 7, except for a proximal protruding portion of the body that extends beyond the opening 12 in the closure cap 9. This protruding portion of the injection pen 7 is held by a user and is pulled or retracted proximally toward the user while the user holds the proximal elongated outer body component 2a when arming the automatic inserter device 1. Figure 2A also shows a pen distal end abutment mechanism for the injection pen, comprising a lever arm 23 having a first grippable end 24 in a first, non-engaged position, where the grippable end 24 of the lever arm 23 is essentially flush with the outer surface 32 of the distal outer body component 2b. A needle (not shown), covered by a needle guard (33), can be seen protruding from the distal end (4) of the distal outer body component (2b) of the elongate bodies (2a, 2b).

[0072] Figure 2B shows a schematic cross-sectional view of the automatic needle inserter device shown in Figures 1 and 2A. One notable difference between Figures 2A and 2B is that the lever arm (23) of the pen distal end abutment means is rotated by manipulating the grippable end (24) to rotate the lever arm about an axis of rotation (34) located parallel to the central longitudinal axis (6), causing the abutment end (25) of the lever arm to contact and press against the outer surface (35) of the needle mount (36) located at the distal end of the pen injection system (7). The distal outer body component (2b) of the elongate body (2a, 2b) is provided with appropriately configured and dimensioned opposed recesses (37, 38) which, upon actuation, serve as a fulcrum about which the lever arm (23) can rotate. The lever arm (23) is suitably provided with a corresponding complementary protrusion (not shown) extending outwardly at a right angle from the body of the lever arm, which, together with the recesses (37, 38), defines a parallel axis of rotation (34). As can be seen, when a user actuates the lever arm (23) by rotation imparted by lifting the graspable end (25) about the parallel axis of rotation (34), the abutment end (25) of the lever arm (23) moves from a non-abutting position, in which the abutment end (25) is substantially flush with the inner surface (39) of the distal outer body component (2b), to an abutting position, in which the abutment end (25) contacts and presses against the outer surface (35) of the needle mounting portion (36). In this manner, the injection pen system (7) is abutted along the central longitudinal axis (6) before being rotationally locked in an axial position along the central axis (6), as described in more detail below.

[0073] Figure 2B shows a schematic cross-sectional view of a rotationally actuated locking means of an automatic needle inserter, also shown in more detail in Figures 5A and 5B, one of whose components is a compression ring (26) having a nominal thickness and a nominal inner diameter that defines a central bore (40). As can be seen in Figure 2B, the compression ring (26) is positioned coaxially with the longitudinal bore (6) of the elongated inserter body (2a, 2b) and, in the unloaded position of the needle inserter device (1), is located in a distal region of the proximal outer body component (2a), near the distal end (16) of the proximal outer body component (2a). In the unloaded position, the compression ring (26) is free to rotate about the central longitudinal axis (6).

[0074] As shown in more detail in Figures 5A and 5B, when the proximal outer body component (2a) is rotated about its central longitudinal axis to initiate rotational locking from a first unlocked position to one or more second locked positions that are appropriately indexed to correspond to the outer diameters of various injection pens currently available and adapted for introduction into an automatic needle inserter device, the inward-facing surface (41) of the proximal outer body component (2a) interacts with and engages one or more radially outward-facing protrusions (42, 43, 44) shown in Figures 5A and 5B. The inward-facing surface (41) of the proximal outer body component (2a) is provided with one or more spaced apart, radially inward-facing ridges (45, 46, 47, 48, 49, 50) that extend axially at least partially parallel to the central longitudinal axis (6) from a location proximal to the proximal end (16) of the proximal outer body component (2a) that defines corresponding grooves or runnels (51, 52, 53) between each pair of ridges. The compression ring bore (40) has an inner diameter sufficient to receive at least a portion of a slidable carriage assembly (27) therein and to permit rotation of the compression ring about the central longitudinal axis (6) within the bore of the proximal outer body component (2a) in the unloaded position.

[0075] In the embodiment shown in Figures 4A and 4B, the slidable carriage assembly (27) includes a carriage body (72, 73) having a proximal portion (72) and a distal portion (73). The proximal portion (72) and the distal portion (73) are assembled coaxially along a central longitudinal axis and define an arcuate region around which the compression ring (26) is positioned. As can be seen in Figure 4A, the proximal portion (72) of the carriage assembly is provided with a distal end (74) having an inwardly projecting annular shoulder or skirt (75), which defines a distally facing surface (76). The distal portion (73) of the carriage body preferably is provided with a pair of diametrically opposed, radially spaced arcuate walls (77, 78) extending proximally from a distally located, radially outwardly projecting ridge (79). The longitudinal edges of each of the opposing arcuate walls (77, 78) define at least one pair, and preferably at least two pairs, of diametrically opposed spaces (80, 81) therebetween, and the proximal ends (82, 83) of the arcuate walls (77, 78) are received in annular grooves (not shown) in the annular shoulder (75). The proximal ends (82, 83) of the arcuate walls may suitably include radially outwardly extending hooks (84), for example, received in corresponding annular grooves in the shoulder (75). In this manner, the proximal-facing surface (86) of the ridge (79) and the distal-facing surface (76) of the skirt (75), together with the arcuate walls (77, 78), define an area for receiving and positioning the compression ring (26). In a particularly advantageous embodiment, the proximal portion (72) and the compression ring (26) are unitary, coaxially aligned, and configured to rotate together about the central longitudinal axis (6) during rotational locking.

[0076] The rotation locking means also includes a compressible membrane (87) of a resilient material, such as an elastomer, e.g., an SEBS elastomer, as described elsewhere herein. The compressible membrane is preferably formed in the shape of a ring and has an aperture (88). The compressible membrane ring (87) is positioned within the aperture of the slidable carriage assembly (27), and more particularly, is seated in non-rotational engagement within the aperture of the proximal portion (73) of the carriage body between the arcuate walls (77, 78). The compressible membrane ring (87) further includes at least one pair, and preferably one, two, three, or even four pairs of diametrically opposed, radially outwardly extending protrusions (89, 90) of compressible material, which may more preferably be formed from an SEBS elastomer having a lower compressibility or a higher Shore hardness than the remainder of the compressible membrane ring. Diametrically opposed radially outwardly extending protrusions (89, 90 and 89', 90') of compressible material may be formed, e.g., extending from shoulders (91) of reduced thickness relative to the protrusions extending at least partially around the circumference of ring (87), and shoulders (91) preferably lie flush with the outer surfaces of arcuate walls (77, 78) to form a continuous arcuate surface. Shoulders (91) serve as contact surfaces that engage the outer peripheral edges of arcuate walls (77, 78), thereby radially positioning radially outwardly extending protrusions (89, 90) within spaces (80, 81) defined by the edges of the arcuate walls such that compressible membrane ring (87) cannot rotate relative to arcuate walls (77, 78).

[0077] As can be seen from the above, during rotation of the compression ring (26) from the unlocked position to one or more second locked positions, the compression ring (26) is brought into contact with the exposed radially outwardly extending protrusions (89, 90; 89', 90') of the compressible membrane ring (87). The inner diameter of the compression ring (26) is variable across the inner circumference defining the inner diameter. In the exemplary illustrated embodiment, this variation is represented by a gradual thickening of the compression ring around the central axis (6) from a portion of the inner diameter greater than the nominal inner diameter (FIG. 5A, 94) to a portion of a smaller or reduced diameter than the nominal inner diameter, the portion (95) having an increased thickness and preferably including an inwardly facing protrusion (96). Similarly, the compression ring has a diametrically opposed, gradual thinning from a compression ring portion (97) having a reduced inner diameter, i.e., increased thickness, relative to the nominal inner diameter, and a corresponding thicker inward-facing protrusion (98) to a compression ring portion (99) having a larger inner diameter, i.e., reduced thickness, relative to the nominal inner diameter. Due to the gradual change in inner diameter, the compression ring (26) exerts gradual compression on the radially outward-facing protrusions (89, 90) of the compressible membrane (87) as the compression ring (26) is rotated in a first direction about the central axis (6) through engagement of the inner circumferential surface of the compression ring (26) with the radially inward-protruding ridges (89, 90) of the proximal outer body component (2a). This exerted radial compression deforms the compressible membrane (87) radially inward, moving the inward-facing surface of the compressible membrane into elastic, frictionally engaging contact with the outer surface of the body of the pen injection system (7). Over-rotation, and therefore over-compression, of the compressible membrane (87) can be prevented by inwardly facing protrusions (96, 98) that are provided with corresponding rotational abutment surfaces that contact the outwardly facing protrusions (89, 90) of the compressible membrane, thereby limiting the rotation angle of the compression ring (26) about the central axis (6).As can be seen, rotating the compression ring in the opposite direction relieves the compression applied to the compressible membrane 87, thereby removing the resilient frictional engagement contact between the compressible membrane and the body of the pen injection system 7, thereby allowing the body of the pen injection system 7 to be removed from the automatic needle inserter device, for example, to store or replace the pen for future injections.

[0078] The slidable carriage assembly (27) also includes two slider arms (100, 101) extending distally, spaced radially equidistant from the distal portion (73) of the slidable carriage assembly, and attached to the distal portion (73) at outwardly protruding ridges (79) also provided on the distal portion of the slidable carriage assembly. The slider arms (100, 101) extend parallel to the central longitudinal axis (6) and are positioned radially about the axis (6). The slider arms (100, 101) terminate in a corresponding pair of abutment edges (102, 103). The two slider arms (100, 101) serve to stabilize the translational movement of the slidable carriage assembly along the central longitudinal axis (6) and, after a rotational lock is established, prevent rotation of the slider assembly about the central longitudinal axis (6) when moving the slidable assembly from the unloaded position to the loaded position. Additionally, the slider arms (100, 101) are preferably positioned angularly opposed to radially spaced arcuate protruding walls (77, 78) extending proximally from the distal portion (73) of the carriage body. In other words, considering the central axis (6) as the center of the clock face, and the clock face on which the slider arms and arcuate walls are disposed, the slider arms (100, 101) are at the 12 o'clock and 6 o'clock positions, respectively, extending forward from the clock face, and the arcuate protruding walls (77, 78) are at the 3 o'clock and 9 o'clock positions, respectively, extending rearward from the clock face and around the clock face. In such an imaginary projection, the arcuate walls (77, 78) extend around the clock face to form arcuate surfaces from about 1 to about 5 o'clock and from about 7 to about 11 o'clock, respectively, with the gaps therebetween corresponding to spaces (80, 81) configured to receive the radially outwardly extending protrusions (89, 90) of the compressible membrane (87). The ridge (79) forming the distal end of the distal portion (73) of the carriage body comprises a series of ridges (104) and grooves (105), the ridges projecting radially outward.The ridges 104 and grooves 105 of the distal ridge 79 engage in sliding contact with correspondingly shaped grooves or runnels and ridges on the inner-facing surface 41 of the outer body component 2a to facilitate translation of the slidable carriage assembly within the bore of the proximal outer body component 2a, but do not interfere with rotation and rotational engagement of the proximal outer body component 2a with the compression ring 26 during rotational locking and unlocking. The different distribution and extension of the grooves and ridges on the proximal outer body component 2a are selected to allow rotation of the compression ring 26 about the central axis 6 for rotational locking and unlocking while also translating the slidable carriage assembly 27 along the central axis 6 with the compression ring 26 for arming and needle insertion and / or disarming.

[0079] As shown in FIG. 3A , which illustrates the various components of the pen injection system 7 and slidable carriage assembly, in the loaded position, the slider arms 100, 101 engage in axial sliding contact with corresponding runnels 106, 107 provided on the elongated distal outer body component 2b. The runnels 106, 107 extend from the proximal end 17 of the elongated distal outer body component 2b toward the distal end 4 of the distal outer body component and are suitably provided on the interior-facing surface 108 of the distal outer body component. The slider arms 100, 101 slidably engage within the correspondingly positioned runnels 106, 107, thereby permitting translational movement of the carriage assembly 27 in both the proximal and distal directions. Assuming that the distal portion (73) of the carriage assembly is translatably coupled to the proximal portion (72) of the carriage assembly via the proximal ends of the arcuate walls (77, 78), which engage the annular groove (84) via their corresponding outwardly projecting hooks or spurs, the slidably engaged arms prevent the distal outer body component (2b) from rotating about the central longitudinal axis (6) relative to the proximal outer body component (2a) during deployment of the inserter device, as well as prevent release of the slidable carriage assembly to the undeployed position. The sliding or translational movement of the carriage assembly (27) in the distal direction along the longitudinal axis is further limited by the length of the slider arms (100, 101) and corresponding runnels (106, 107), each having a distal end (102, 103) that forms an abutment stop with a corresponding distal end (109, 110) of a corresponding runnel (106, 107) provided on the distal outer body component (2b). As can be seen, therefore, the slider arms (100, 101) have a length sufficient to extend distally into and maintain sliding engagement contact with corresponding runnels (106, 107) on the elongated distal outer body component (2b) when the slidable carriage assembly is in the armed position to continue to prevent rotation of the carriage assembly (27) holding the pen injection system about the central axis (6).

[0080] The slidable carriage assembly (27) further comprises a releasable trigger means (111) having a trigger member (112) configured to hold the slidable carriage assembly (27) in the armed position until the trigger member (112) is released. The releasable trigger member (112) is provided to allow a user to perform an injection, and upon release of the trigger, the pen injection system (7) moves distally from the armed position to an injection position where a needle of the pen injection system penetrates an injection surface, such as the skin. A biasing element (21), such as a compression spring, provides the impetus for moving the pen injection system (7) from the armed position to the unarmed position via an injection operation. Thus, the slidable carriage assembly is moved to the armed position by the user of the inserter device 1 pulling on the pen injection system 7, which is held to the slidable carriage assembly 27 by the compression ring 26 and compressible membrane 87, or by the user exerting a traction force on the pen injection system 7, the traction force being exerted in a proximal direction, after rotationally actuated locking of the pen injection system as described elsewhere herein. Essentially, the user of the automatic needle inserter pulls the pen body proximally backward against the biasing element 21 to compress the biasing element 21 until the trigger member 112 of the releasable trigger is locked and the armed position is established. The trigger member 112 comprises a resiliently deformable arm movable from a first longitudinal alignment plane in the unarmed position to a different second longitudinal alignment plane in the armed position. The elastically deformable arm (112) extends radially outward in a proximal direction from the proximal body portion (72) of the carriage assembly (27). The elastically deformable arm (112) lies along a first longitudinal plane that is parallel to the central longitudinal axis (6) in an undeformed, unloaded state. When the slidable carriage assembly (27) is moved proximally, the elastically deformable arm (112) contacts an abutment (113) located adjacent the proximal end of the proximal outer body component (2a). Figure 3B shows a cross-sectional view of the elastically deformable arm (112) in the engaged, loaded position.The abutment (113), which is in the same longitudinal plane as the elastically deformable trigger arm (112), allows the arm to elastically deform and move from a first longitudinal plane to a second longitudinal plane radially spaced from the first longitudinal plane. In the embodiment illustrated herein and shown, for example, in FIG. 3B, the trigger arm (112) is elastically deformed from the first longitudinal plane via a suitably shaped angled protrusion (113) that extends into and defines the proximal end of a notched channel (114) in the interior-facing surface of the proximal outer body component (2a). The notch (114) defines the angled protruding abutment (113), which further includes a proximal hook end (115) that interacts with and engages a corresponding complementary hook end (116) on the trigger arm (112). When the trigger arm is elastically deformed from the first longitudinal plane to the second longitudinal plane by the angled protruding abutment (113), the hook end (116) of the trigger arm (112) is moved around the hook end (115) of the abutment, after which, upon further proximal movement, the hook end (116) of the trigger arm (112) captures the hook end (115) of the angled protruding abutment (113). At this point, the inserter device is in the armed position until the trigger is released.

[0081] The trigger release is provided by a release button (15) located on the proximal outer body component (2a), which in the illustrated exemplary embodiment is located on the closure cap (9), but which could also be directly integrated, for example, by appropriate molding of the proximal outer body component (2a). The release button (15) includes a resiliently deformable tongue (117) extending distally and positioned over the trigger arm (112). The release button (15) also includes an inspection orifice (118) positioned over the proximal end of the trigger arm, which allows the user to verify at a glance that the trigger arm is in the proper position, i.e., that the inserter device is correctly equipped. Such visualization can be facilitated, for example, by providing the trigger arm with a color that is visible through the inspection orifice (118). The resiliently deformable tongue (117) of the release button lies substantially flush with the outer surface of the proximal outer body component but is deformable by a downward depression exerted by a user when the user wishes to actuate the release of the inserter device (1) and advance the slidable carriage assembly distally to insert the pre-loaded, exposed needle into a target site for injection. Thus, when the tongue (117) is depressed downward, the inward-facing surface of the tongue (117) contacts the proximal end of the trigger arm (112) and the arm resumes its normal resting elastic constraint, moving the resiliently deformable arm (112) from the second longitudinal alignment plane back to the first longitudinal alignment plane, thereby releasing the trigger member (112) from the armed position. The trigger member (112) is free to slide back through the notched channel (114) under the impetus of the detent energy stored in the compression spring (21) as the compression spring (21) re-expands to its unconstrained position.

[0082] Referring again back to the slidable carriage assembly (27), the assembly is provided with surface engagement means comprising at least one protruding contact member (FIGS. 3A, 4A, 119) extending radially outward from the slidable carriage assembly proximally beyond the proximal end of the slidable carriage body proximal portion (72). This contact member (119) engages in axial sliding contact with at least one corresponding runnel or groove described elsewhere herein on the proximal outer body component (2a). The runnel is sized and configured to surround the protruding contact member (119) and thereby help prevent rotation of the carriage assembly (27) about the central longitudinal axis (6) as the carriage assembly (27) translates from the unloaded position to the loaded position and vice versa. The contact member (119) can be preferably represented as a series of radially spaced, outwardly projecting legs (119) located on the outward-facing surface of the carriage body first proximal portion (72) and extending along the carriage body beyond its proximal end parallel to the central longitudinal axis (6). The length of the projecting legs extending beyond the proximal end of the carriage body is set to provide an appropriate abutment distance between the proximal end of the carriage body and the proximal end (3) of the outer elongate body (2a, 2b), thereby limiting the proximal travel distance of the carriage body. Furthermore, the contact member legs are sized and configured to engage the distal end of the biasing spring (21), compressing the spring (21) when the slidable carriage assembly is moved from the unloaded position to the loaded position and serving as a contact surface for driving the slidable carriage assembly in the reverse direction when the release button of the needle inserter device is actuated.

[0083] Here, we briefly describe the use of the automatic needle inserter device (1). The pen distal end abutment lever arm (23) is manipulated via the graspable end (24), causing the lever arm to rotate about its axis of rotation and displacing the abutment end (25) of the lever arm into the central longitudinal bore (5). The pen injection system is inserted through the opening (12) in the closure cap (9) into the bore (5) of the elongated outer body (2a, 2b) comprising the assembled proximal and distal outer body components (2a, 2b). The needle mounting surface of the needle mounting portion on the injection pen abuts against the abutment end (25) of the abutment lever arm 23. The abutment end (25) remains in place within the bore (5) until the body of the injection pen (7) is rotationally locked. Rotational locking occurs by rotating the proximal outer body component about the central longitudinal axis (6), thereby rotationally driving the compression ring (26) and the proximal portion (72) of the slidable carriage assembly (27). The corresponding rotation of the compression ring (26) presses the compressible membrane (87) onto the body of the injection pen (7). The compression exerted on the injection pen body locks the pen body (7) in an axial position within the bore (5). This position is indicated to the user via corresponding indicia or visual markings (A, B, C, D, E) on the exterior surface of the elongated proximal body component (2a). At this stage, the needle inserter device is rotationally locked but still in the unarmed position. The lever arm (23) is returned to a position flush with the exterior and interior surfaces, respectively, of the distal outer body component (2b), so that the abutment end (25) no longer protrudes into the inserter bore (5). The user then removes the needle guard, exposing the injection needle, and the compression exerted on the body of the injection pen (7) by the compression ring (26) and compressible membrane is sufficient to grasp the pen body with one hand and hold down the elongated outer body (2a, 2b) with the other, after which the pen body (7) is moved proximally to arm the automatic needle inserter.The pen injector (7) translates proximally together with the slidable carriage assembly (27) and compression ring (26) until the trigger member (112) is deflected from its first longitudinal plane to a second longitudinal plane by the angled abutment protrusion defined by the notched channel (114) and the corresponding hooks (115, 116) engage each other to set the inserter device (1) in the armed position. The user applies the distal end (4) and distally facing surface (22) to the intended injection site. Pressing the tongue (117) of the release button (15) moves the trigger member (112) from the second longitudinal plane back to the first longitudinal plane, releasing the hooks (115, 116) from each other, thereby propelling the trigger member, the slidable carriage assembly (27), and the compression ring (26) distally under the impetus of the released energy stored in the compression spring (21). The impetus provided by the spring causes the injection pen (7) and the needle mounted thereon to protrude beyond the distal end (4) of the inserter device to the exact correct depth at the injection site due to the prior axial locking and axial abutment of the injection pen. At this stage, the user can inject the substance to be injected by pressing the activation button on the injection pen (7) in the usual manner. Once the injection is complete, the automatic needle inserter device 1 can be removed from the injection site and the rotational locking means unlocked by rotating the proximal outer body component 2a about the central axis 6 in a direction opposite to the direction of the locking movement. This releases the compression exerted by the compression ring 26 on the compressible membrane 87 and releases the pen injection system 7 from its locked axial position. The injection pen 7 can then be removed and / or replaced as needed for subsequent injections.

Claims

1. an elongate inserter body having a proximal end and a distal end; and a longitudinal bore extending through the elongate body from the proximal end to the distal end, the longitudinal bore having a central longitudinal axis, the elongate inserter body being sized and configured to receive a pen injection system introduced into the bore through the proximal end of the inserter body and being further configured and dimensioned to prevent the pen injection system from exiting the longitudinal bore through the distal end; The elongated inserter body includes: and a rotationally actuated locking means configured to lock the pen injection system in an axial position within the longitudinal bore by rotating at least a portion of the elongated inserter body about the central longitudinal axis from a first unlocked position to at least one or more second locked positions. Automatic needle inserter for pen injection systems.

2. 2. The automatic needle inserter of claim 1, wherein the elongated inserter body comprises at least a first elongated outer body component and at least a second elongated outer body component, and at least one of the at least first elongated outer body component and the at least second elongated outer body component is configured to rotate about the central longitudinal axis relative to at least the other elongated outer body component during locking.

3. 3. The automatic needle inserter of claim 1, wherein the elongated inserter body comprises at least a first elongated outer body component and at least a second elongated outer body component, the at least first elongated outer body component and the at least second elongated outer body component configured to rotate in opposite directions relative to one another about the central longitudinal axis during locking.

4. 2. The automatic needle inserter of claim 1, wherein the rotationally actuated locking means comprises a compression ring having a nominal thickness and a nominal inner diameter defining a central bore, the compression ring being positioned coaxially with the longitudinal bore of the elongated inserter body.

5. The automatic needle inserter of claim 4 , wherein the compression ring has a variable inner diameter relative to the nominal inner diameter.

6. 6. The automatic needle inserter of claim 4 or claim 5, wherein the compression ring comprises at least one portion having an increased inner diameter relative to a nominal diameter.

7. 7. The automatic needle inserter of claim 4, wherein the compression ring comprises at least one portion having a reduced inner diameter relative to the nominal diameter.

8. 8. The automatic needle inserter of claim 4, wherein the at least one portion of the compression ring having an increased inner diameter extends around the inner diameter of the compression ring with an inner diameter that gradually decreases toward the portion of the compression ring having the reduced inner diameter.

9. 5. The automatic needle inserter of claim 4, wherein the compression ring includes at least one portion extending inwardly into the central bore and having an increased thickness relative to the nominal thickness of the ring.

10. 10. The automatic needle inserter of claim 4 and claim 9, wherein the compression ring includes at least one portion extending inwardly into a central bore and having a reduced thickness relative to the nominal thickness of the ring.

11. 11. The automatic needle inserter of claims 4, 9, and 10, wherein the at least one portion of the compression ring having an increased thickness extends circumferentially inward from the outer periphery of the compression ring into the central bore with a gradually decreasing thickness toward the portion of the compression ring having the decreased thickness.

12. 2. The automatic needle inserter of claim 1, wherein the rotationally actuated locking means further comprises a compressible membrane of resilient material.

13. 13. The automatic needle inserter of claim 4 and claim 12, wherein the compressible membrane of resilient material is coaxially positioned within the bore of the compression ring.

14. 14. The automatic needle inserter of claim 13, wherein the compressible membrane is compressed from a relaxed state to a compressed state by rotational movement of the compression ring about the central longitudinal axis from the first unlocked position to the one or more second locked positions.

15. 15. The automatic needle inserter of claim 14, wherein an inwardly facing surface of the compressible membrane is brought into contact with an exterior surface of the body of the pen injection system by rotational movement of the compression ring about the central longitudinal axis from the first unlocked position to the one or more second locked positions.

16. 5. The automatic needle inserter of claim 4, wherein the compression ring is attached or mounted to a slidable carriage assembly configured to translate the compression ring along the central longitudinal axis from an unloaded position to a loaded position.

17. 17. The automatic needle inserter of claim 16, wherein the slidable carriage assembly includes a bore coaxially aligned with the bore of the compression ring.

18. 18. The automated needle inserter of claim 16 or claim 17, wherein at least a portion of the slidable carriage assembly is configured to co-rotate with the compression ring about the central longitudinal axis.

19. 19. The automatic needle inserter of any one of claims 16 to 18, wherein the slidable carriage assembly and compression ring each comprise surface engagement means configured to slidingly engage a first elongate outer body component to enable the compression ring to be translated with the slidable assembly from the undeployed position to the deployed position.

20. 20. The automatic needle inserter of claim 19, wherein the surface engaging means of the slidable carriage assembly comprises at least one protruding contact member extending radially outward from the slidable carriage assembly.

21. 21. The automatic needle inserter of claim 20, wherein the at least one protruding contact member extending radially outward from the slidable carriage assembly is in axial sliding engagement with at least one corresponding runnel on the first outer elongate body component.

22. 22. The automatic needle inserter of claim 20 or claim 21, wherein the at least one protruding contact member extending radially outward from the slidable carriage assembly also extends proximally beyond the proximal end of the slidable carriage assembly.

23. 17. The automated needle inserter of claim 16, wherein the slidable carriage assembly comprises at least one slider arm extending distally from a distal portion of the carriage assembly parallel to the central longitudinal axis.

24. 24. The automatic needle inserter of claim 23, wherein the at least one slider arm is in axial sliding engagement with at least one corresponding runnel on the second outer elongate body component.

25. 25. The automatic needle inserter of claim 24, wherein the at least one slider arm has a length sufficient to extend distally into and maintain sliding engagement contact with the corresponding runnel on the second elongate outer body component when the slidable carriage assembly is in the armed position.

26. 20. The automatic needle inserter of claim 19, wherein the compression ring includes at least one protruding contact member extending radially outward from the compression ring.

27. 27. The automatic needle inserter of claim 26, wherein the at least one protruding contact member extending radially outward from the compression ring is in axial sliding engagement with at least one corresponding runnel on the first outer elongate body component.

28. 17. The automatic needle inserter of claim 16, wherein the slidable carriage assembly further comprises a releasable trigger means having a trigger member, the trigger means configured to hold the slidable carriage assembly in the armed position until the trigger member is released.

29. 30. The automatic needle inserter of claim 28, wherein the trigger member comprises a resiliently deformable arm movable from a first longitudinal alignment plane in the unarmed position to a second longitudinal alignment plane in the armed position.

30. 30. The automatic needle inserter of claim 29, wherein the first elongate outer body component comprises a release button configured to release the trigger member from the armed position by moving the resiliently deformable arm from the second longitudinal alignment plane to the first longitudinal alignment plane.

31. 10. The automatic needle inserter of claim 1, further comprising selectively actuable pen distal end abutment means configured to abut a distal end of the pen injection system upon insertion of the pen injection system into the longitudinal bore of the elongate inserter body along the central longitudinal axis of the longitudinal bore.

32. 32. The automatic needle inserter of claim 31, wherein said selectively actuatable pen distal end abutment means is movable from a first, non-abutted position to a second, abutted position.

33. 33. The automatic needle inserter of claim 31 or claim 32, wherein the selectively actuatable pen distal end abutment means is located adjacent or proximate to the distal end of the elongate inserter body.

34. 32. The automatic needle inserter of claim 31 , wherein the selectively actuatable pen distal end abutment means comprises an articulated arm member configured to rotate about an axis aligned parallel to the central longitudinal axis, the articulated arm member being rotatable about the parallel axis of rotation from the first non-abutted position to the second abutted position.

35. 35. The automatic needle inserter of claim 34, wherein the articulated arm member lies flush with the elongate inserter body in the first non-butting position and extends into the longitudinal bore in the second abutting position.

36. 36. The automatic needle inserter of any one of claims 31 to 35, wherein rotationally actuated locking of the pen injection system occurs only after abutment of the pen injection system by selective operation of the abutment means.

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