• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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  • 优先权
    • 专利摘要:
    intradermal injection adapter. an intradermal injection assembly to inject a drug into the skin could form an intradermal needle with an adapter, an intradermal syringe with an adapter or an adapter for a junction with the syringe and cannula. the intradermal adapter in these devices has a body having a longitudinal geometric axis, a central part having a cannula channel and a distal protuberance, generally extending parallel to the longitudinal axis, the distal protuberance of the adapter has a first contact surface at skin extending, in general, parallel to the longitudinal axis. at least a part of the distal protuberance is generally transparent, so that the part of the cannula that extends distally in relation to a demarcation plane can be visualized through the distal protuberance, during insertion of the cannula into the patient's skin.
    公开号:BR112012001498B1
    申请号:R112012001498-6
    申请日:2010-07-23
    公开日:2020-09-24
    发明作者:Izrail Tsals
    申请人:Program For Appropriate Technology In Health；
    IPC主号:
    专利说明:

    [0001] This application claims the benefit of Provisional Patent Application US 61 / 271,565, filed on July 23, 2009 and entitled "Devices and Methods for Intradermal Injection", 61 / 283,249, filed on December 2, 2009 and entitled "Pivoting Adapter for Intradermal Injection ”and 61 / 343.045, filed on April 19, 2010 and entitled“ Needle Assemblies and Prefilled Syringes for Intradermal Injection ”, each of which is incorporated herein by reference in its entirety. Fundamentals of the invention
    [0002] Intradermal injections are used to apply a variety of diagnostic and treatment compositions to a patient. Intradermal injections are typically injections of a relatively small amount of medication into the dermis or dermal layer or even into a lower portion of the epidermis (figure 2A) of a patient's skin. The substances can be injected intradermally for diagnostic testing, such as to determine the patient's immunity against tuberculosis and the state of allergic diseases. Vaccines, drugs and other compounds can also be applied intradermally. In many cases, intradermal application is preferred because it generally requires a lower volume dose of the diagnostic or treatment compound than other application techniques. There is considerable variation in the thickness of a patient's skin, both between individuals and within the same individual at different locations on the body. Generally, the outer layer of the skin, or the epidermis, is typically between two and five hundred microns thick (200 - 500 μm) and the dermis, the innermost and thickest layer of the skin, generally has a thickness between one and a half to three and a half millimeters (1.5 - 3.5 mm).
    [0003] Giving intradermal injections is difficult and usually requires an experienced nurse or medical professional. Incorrect placement of the cannula tip can lead to an unsuccessful injection. Placement of the cannula tip deeper than approximately three millimeters (3.0 mm) has the potential to deliver the injection to the subcutaneous region, where intradermal dosage may be insufficient. Incorrect placement of the cannula can also pierce the skin again after being inserted into the dermis, with the applied compound being lost on the skin surface. The injection is often followed by a jet effect, with the compound leaving the injection site through the drill path. The jet effect is even more pronounced for injections through a cannula placed perpendicular to the injection site and in particular for surface application. The success of intradermal injections is often determined by the expertise and experience of the individual health care professional who administers the injection. The preferred intradermal injection technique (using a standard cannula) requires the healthcare professional to stretch the skin, orient the cannula bevel to turn upward and insert a short bevel cannula at an angle of approximately ten to fifteen degrees ( 10 - 15 °) in relation to a skin surface, while also ensuring that two to three millimeters (2 - 3 mm) of the cannula are located on the skin. The tip of the cannula ends ideally positioned in the dermis or close to the limit of the dermis / epidermis. The compound is slowly injected into the patient's skin, forming a blister or pustule. Inserting the cannula at an incorrect angle and / or depth results in an unsuccessful intradermal injection, which is typically repeated, causing additional pain and discomfort, as well as ineffective treatment for the patient. Intradermal injection (ID) has been considered for immunization in the past, but has generally been rejected in favor of more reliable intramuscular or subcutaneous routes of administration because of the difficulty of delivering successful ID injections, particularly when the injections are administered by care professionals relatively inexperienced health workers.
    [0004] Administration in the intradermal space region has been used routinely in the Mantoux tuberculin test, in which a purified protein derivative is injected at a superficial angle to the skin surface using a twenty-seven (27) or thirty (30) cannula. ) and a standard syringe. The technique is known to be very difficult to perform and usually requires specialized training. The degree of inaccuracy in the placement of the injection results in a significant number of false negative test results. As a result, Mantoux's approach did not lead to the use of intradermal injection for the systemic administration of substances, despite the advantage of requiring lower doses of substances, because the absorption of the drug in the dermal layer of the skin is typically superior to the injection of the same substance. using alternative techniques.
    [0005] It would be desirable to design and manufacture an intradermal injection adapter that provides a reliable, relatively simple intradermal injection, is relatively easy to use, relatively cost effective for the user and limits drug waste. The cannula of the intradermal injection adapter is preferably statically mounted on or attached to an adapter body and / or a syringe tube in an assembled configuration. Brief summary of the invention
    [0006] Briefly stated, in a preferred aspect, the present application is directed to a syringe assembly for delivering intradermal injections comprising a syringe tube having a proximal end and a distal end. A cannula is attached at the distal end of the syringe tube. A protuberance is attached at the distal end of the syringe tube, having a first skin contact surface separated from and generally parallel to the cannula. At least a portion of the protuberance near a distal end of the cannula is generally transparent to allow the cannula to be visible with insertion into a patient's skin.
    [0007] In addition, the syringe assembly may comprise an adapter having a body with a proximal end and a distal end. The proximal end of the body can be joined at the distal end of the syringe tube. The cannula is joined at the distal end of the body. And the bulge is joined at the distal end of the body.
    [0008] In addition, the syringe assembly may comprise an adapter having a body with a proximal end and a distal end, the body being able to be joined at the distal end of the syringe tube. The protuberance is swiveled to the body. The protrusion may include a cannula support element to align the cannula to generally be in parallel with the first skin contact surface.
    [0009] In addition, the syringe assembly may comprise an adapter having a body with a proximal end and a distal end, the body being able to be joined at the distal end of the syringe tube and the protuberance being joined at the distal end of the body. A second skin contact surface is joined at the distal end of the body. The cannula extends distally between the protuberance and the second skin contact surface. At least one support member is joined to the body to align the cannula to generally be in parallel with the first skin contact surface.
    [0010] In another aspect, a preferred embodiment of the present invention is directed to an intradermal injection adapter having a cannula for delivering an in-translation injection. The adapter includes a body having a longitudinal geometric axis, a central portion and a distal protuberance. The central portion is located distally in relation to the body along the longitudinal geometric axis. The central portion has a cannula channel through it that generally extends parallel to the longitudinal geometric axis. The cannula channel defines an edge of the cannula channel. The distal protuberance has a first skin contact surface that generally extends parallel to the longitudinal geometric axis. The first skin contact surface is spaced from the cannula, such that a distal portion of the cannula generally extends parallel to the first skin contact surface. The distal protrusion is generally transparent in the distal direction with respect to a defined demarcation plane where the cannula extends across the edge of the cannula channel, such that the distal portion of the cannula can be seen through the distal protrusion during insertion of the cannula into skin of a patient.
    [0011] In another aspect, a preferred embodiment of the present invention is directed to an intradermal injection kit for injecting a drug into the dermal layer of the skin. The set includes a syringe including a cannula, a hub, a tube and a plunger and an adapter having a body with a syringe channel, a central portion and a distal protrusion. The tube has a generally cylindrical configuration and a hollow internal cavity adapted to receive the medication in it. The central portion has a cannula channel defining an edge of the cannula channel. The distal protuberance has a distal bill. The adapter also includes a proximal end portion and a longitudinal geometric axis that extends between the proximal end portion and the distal tip. The distal protuberance includes a first skin contact surface generally positioned parallel to the longitudinal geometric axis. A distal portion of the cannula is spaced from the first skin contact surface at an opening distance from the cannula in the assembled configuration. A cannula tip is positioned distally from the cannula channel edge in an assembled configuration.
    [0012] In yet another aspect, a preferred embodiment of the present invention is directed to a method of injecting a drug into a dermal layer of the skin of a patient's skin using an adapter and syringe assembly including a distal protuberance having a relatively transparent portion towards distal in relation to a defined demarcation plane where the cannula crosses an edge of the cannula channel and a relatively opaque portion proximal to the demarcation plane. The adapter also includes a first skin contact surface positioned generally parallel to a distal portion of the cannula, a central portion and a longitudinal geometric axis. The method includes the steps of placing the adapter close to the patient's skin, such that the longitudinal geometric axis is usually parallel to the users' skin, applying a force in the set towards the skin and generally parallel to the skin to slide the adapter and the syringe assembly along the patient's skin and insert the cannula into the patient's skin, visually monitor the insertion of the cannula into the users' skin and the positioning of the patient's skin in relation to the first skin contact surface through the relatively portion transparent from the distal protuberance, confirm that the cannula is at least partially positioned inside the patient's skin in an injection position and inject the medication into the dermal layer of the skin.
    [0013] In an additional aspect, the present application is directed to an intradermal injection adapter for mounting on a syringe having a cannula for delivering an intradermal injection. The adapter includes a body having a longitudinal geometric axis and a syringe channel configured to receive at least a portion of the syringe therein. A central portion has a cannula channel that generally extends parallel to the longitudinal geometric axis. The cannula channel defines an edge of the cannula channel. A distal protuberance generally extends parallel to the longitudinal geometric axis. The distal protuberance has a first skin contact surface that generally extends parallel to the longitudinal geometric axis. The first skin contact surface is spaced from the longitudinal geometric axis and is generally continuous between an area adjacent to a tip of the cannula and an area adjacent to the edge of the cannula channel in an assembled configuration. The distal protuberance is generally transparent in the distal direction and generally opaque in the proximal direction with respect to a defined demarcation plane where the cannula extends over the edge of the cannula canal. The demarcation plane is generally perpendicular to the longitudinal geometric axis. The tip is positioned distally in relation to the demarcation plane in the assembled configuration. Brief description of the drawings
    [0014] The preceding summary, as well as the following detailed description of the invention, will be better understood when read in conjunction with the accompanying drawings. In order to illustrate the invention, modalities that are currently preferred are shown in the drawings. It should be understood, however, that the invention is not limited to the precise provisions and means shown. In the drawings: Figure 1 is a top perspective view of a syringe and an adapter according to a first preferred embodiment of the present invention, Figure 2 is a side projection view of the syringe mounted on the adapter of Figure 1 in a configuration assembled with the cannula inserted into the skin of a patient in the process of applying an intradermal injection, Figure 2A is a sectional view of the patient's skin taken from inside the box 2A of figure 2, Figure 3 is a front perspective view of the adapter in Figure 1, Figure 3A is an enlarged rear perspective view of a cannula channel of the Figure 1 adapter, Figure 4 is a side view of the adapter in Figure 1, Figure 5 is a rear perspective view of the adapter in Figure 1, Figure 6 is a top plan view of the adapter in Figure 1, Figure 7 is a sectional view of the adapter in Figure 1, taken along line 7-7 in Figure 6, Figure 8 is a rear projection view of the adapter in Figure 1, Figure 9 is a bottom plan view of the adapter in Figure 1, Figure 10 is a front projection view of the adapter in Figure 1, Figure 11 is a top perspective view of an adapter according to a second preferred embodiment of the present application, Figure 12 is a projection view on the right side of the adapter in Figure 11, Figure 13 is a bottom plan view of an adapter according to a third preferred embodiment of the present application, Figure 14 is a view of the lower flat section of the adapter of Figure 13 mounted on a syringe in an injection position, Figure 15 is an enlarged bottom plan view of the adapter of Figure 13 mounted on the distal end portion of a syringe, Figure 16 is a partially exploded view in the right side of an adapter and syringe according to a fourth preferred embodiment of the present application and Figure 17 is a partially exploded top plan view of the adapter and syringe of Figure 16. Detailed description of the invention
    [0015] Certain terminology is used in the following description for convenience only and is not limiting. The words "right", "left", "lower" and "upper" indicate directions in the drawings to which reference is made. The words "inward" or "proximally" and "outward" or "distally" refer to directions near and away from, respectively, the geometric center or orientation of the adapter, adapter and syringe assembly or other related parties of them. The words "join", "which can be joined" and "joined" mean "together" or "linked", by direct interlocking or through intermediate components. The terminology includes the words listed above, their derivatives and words of similar meaning.
    [0016] With reference to figures 1-10, a first preferred embodiment of the present invention is directed to an intradermal injection adapter 10 for mounting on a syringe 12 having a cannula 14 for delivering an intradermal injection to the skin of a patient S. In the first preferred embodiment , the adapter includes a side opening 22 that extends along the entire length of the adapter 10, generally parallel to the longitudinal geometric axis 18. The side opening 22 allows the insertion of syringe 12 into the adapter 10 to inject the drug into a patient in an assembled configuration, where a tip 14a of a cannula 14 is spaced distally from an edge of the cannula channel 26a of adapter 10 and is generally fixed in that position in the assembled configuration. The side opening 22 specifically allows a medical professional to engage the syringe 12 with the adapter 10 prior to injecting the drug into the patient. Typically, adapter 10 is packaged in a sterile package and removed from the package for assembly with syringe 12 prior to injection of the drug into the patient. In this way, a plurality of packaged adapters 10 and a plurality of syringes 12 can be stored at an injection site and assembled when necessary to inject the drug into patients.
    [0017] Adapter 10 is not limited to the inclusion of side opening 22 (see figures 11-17), but side opening 22 allows relatively easy assembly or engagement of syringe 12 with adapter 10. For example, adapter 22 can be sold as an individual sterile unit for a medical organization or other user and mounted on a pre-filled syringe 12 prior to injecting the medicine into skin S. However, adapter 10 can also be configured to eliminate side opening 22 such that syringe 12 is introduced into the syringe channel 20 through a portion of the proximal end 16a of a body 16 of the adapter 10 (see figures 13-15). In addition, adapter 10 can be configured such that adapter 10 is permanently attached to or molded into syringe 12, body 16 being permanently attached, bonded with adhesive, formed or otherwise permanently attached or attached to syringe 12 (see figures 16 and 17). Adapter 10 is used preferably by healthcare professionals, but can also be used by professionals outside the healthcare field, potentially for self-injection and typically when adapter 10 is pre-assembled in syringe 12 (see, for example, figures 16 and 17).
    [0018] The intradermal injection adapter 10 also includes a central portion 24 having a cannula channel through it which generally extends parallel to the longitudinal geometric axis 18. The cannula channel defines the edge of the cannula channel 26a which tapers slightly distally in the first preferred embodiment, but it can generally be oriented perpendicular or otherwise to the longitudinal geometric axis 18. For example, the cannula channel edge 26a can be oriented in various configurations or in various orientations to accommodate the introduction of the cannula 14 into the cannula channel. cannula 26, to align cannula 14 with adapter 10 or for various other design considerations. In the assembled configuration, at least a portion of the cannula 14 is received within the cannula channel 26 and a distal portion of the cannula 14 extends beyond the cannula channel 26. The edge of the cannula channel 26a is not limited to being positioned generally perpendicular to the longitudinal geometry axis 18 and can be tilted or otherwise oriented with respect to the longitudinal geometry axis 18 and be slightly inclined with respect to the longitudinal geometry axis 18 in the first preferred embodiment (see figures 4 and 9). In the first preferred embodiment, a demarcation plane 27 is defined where the cannula 14 extends over the edge of the channel 26a, is generally perpendicular to the longitudinal geometric axis 18 and intersects the longitudinal geometric axis 18. The tip 14a of the cannula 14 is positioned in the distal to the demarcation plane 27 when the syringe 12 and adapter 10 are in the assembled configuration and the cannula 14 and the tip 14a generally maintain their position in relation to the demarcation plane 27 in the assembled configuration and through the injection process .
    [0019] In the first prepared modality, a second skin contact surface 28 extends proximally to the edge of the cannula channel 26a at a tapered angle Δ. The taper angle Δ can be adjusted or adapted to accommodate dimensions of the adapter 10 and / or the associated syringe 12. At least a portion of the second skin contact surface 28 preferably tapers proximally to the edge of the channel 26a at a relatively shallow angle, such that the second skin contact surface 28 can slide smoothly along the skin S of the patient. The second skin contact surface 28 is not limited to being generally planar or conical, it can be oriented at different angles, it can have a portion that is generally perpendicular to the longitudinal geometric axis 18 (see figures 12 and 16), it can be arched or slightly curved or even have a portion that is generally linear and additional portions that are arched and / or curved.
    [0020] A distal protuberance 30 generally extends parallel to the longitudinal geometric axis 18 from the central portion 24. In the first preferred embodiment, the distal protuberance 30 includes an inclined distal nozzle 32 that curves away from the longitudinal geometric axis 18. The distal nozzle inclined or curved 32 helps the user or medical professional in the arrangement of the adapter 10 in relation to the patient's skin S and generally limits the crushing or abrupt engagement of the distal nozzle 32 with the patient's skin to limit the patient's pain and discomfort . The inclined or curved distal nozzle 32 also encourages relatively smooth sliding of the adapter 10 along the patient's skin S while inserting the cannula 14 into the patient's skin S and guiding the adapter 10 along a path generally parallel or slightly inclined with respect to to the patient's skin S, such that the cannula 14 is inserted into the patient's skin S with the tip 14a positioned on the dermis or dermal layer. The distal protrusion 30 is not limited to the inclusion of the distal nozzle 32 which generally tilts away from the longitudinal geometry axis 18 and can include a blunt edge at a distal end, can be tapered or can be otherwise configured to assist the user or professional positioning of adapter 10 in relation to the patient's skin S.
    [0021] In the first preferred embodiment, the distal protuberance 30 is generally transparent in the distal direction in relation to the demarcation plane 27, such that the cannula 14 can be seen through the distal protuberance 30 during the insertion of the cannula 14 in the skin S and generally throughout the intradermal injection process. Having a generally transparent distal protuberance 30 allows the medical professional, nurse or even the patient to see the cannula 14 through the distal protuberance 30 to ensure that the cannula 14 and particularly the tip 14a is inserted into the patient's skin during the injection . For example, a medical professional may position the cannula 14 in relation to the user's skin and inadvertently not penetrate the S skin in the inclined or uneven areas. Such insertion error can cause the user or medical professional to activate the syringe 12 to eject the medication without the tip 14a positioned on the skin S, thereby losing or wasting the medication. Ejection of the medication with a misplaced cannula 14 where the cannula 14 is not positioned on the patient's skin dermal layer S wastes the medication, which can be relatively expensive, and often requires a second injection, thus typically causing pain and discomfort for the patient. Such a situation can also result in the patient not being vaccinated, potentially without the knowledge of the medical professional or another user. Thus, it is preferred that the distal protuberance 30 is relatively transparent, such that the medical professional, nurse and / or patient can confirm that the cannula 14 is positioned under the surface of the patient's skin S prior to injection. However, the distal protuberance 30 is not limited to being generally transparent and can be opaque.
    [0022] The distal protrusion 30 includes a first skin contact surface 34 that generally extends parallel to the longitudinal geometric axis 18. In the injection position, the first skin contact surface 34 contacts the patient's skin surface S to position the tip 14a of the cannula 14 at a predetermined depth within the skin S, such that the tip 14a is positioned in the dermal layer of the skin S and the drug is injected into the dermal layer for absorption. The first skin contact surface 34 is preferably not discontinuous or does not include an opening or hole at or near the tip 14a to limit the potential for the skin S to enter the opening or hole, thereby causing the position of the tip 14a to be too deep on the patient's S skin or even in a subcutaneous space. In this way, the first generally continuous skin contact surface 34 generally controls the distance between the tip 14a of the cannula 14 and the first skin contact surface 34 to increase the probability that the tip 14a will be positioned on the dermal layer in a injection position (figure 2).
    [0023] In the first preferred embodiment, a first alignment ramp 36 is positioned within the channel of the cannula 26 and is configured to orient the cannula 14 generally parallel to the first skin contact surface 34 in an assembled configuration (figure 2). The orientation of the cannula 14 generally parallel to the first skin contact surface 34 is preferred to control the spacing of the cannula 14 relative to the first skin contact surface 34, such that the tip 14a is positioned on the dermal layer of the skin S of the patient in the injection position (figure 2).
    [0024] The adapter 10 of the first preferred embodiment also includes a second alignment ramp 38 positioned within the cannula channel 26 which is configured to orient the cannula 14 in cooperation with the first alignment ramp 36, generally in parallel with the first contact surface with the skin 34 in the assembled configuration. The second alignment ramp 38 is preferably positioned distally in the cannula channel 26 in relation to the first alignment ramp 36 and the cannula 14 is preferably in confrontation with the first and second alignment ramps. 36, 38 in the assembled configuration. The adapter 10 is not limited to the inclusion of the first alignment ramp 36 or the second alignment ramp 38 to align at least the distal section of the cannula 14 generally in parallel with the first skin contact surface 34 and can include numerous locking mechanisms. alternative alignments or no specific alignment mechanism in the central portion 24 or within the cannula channel 26. For example, the cannula channel 26 may include a V-shaped groove that aligns the cannula 14 generally in parallel with the first contact surface with the skin 34, a clamping mechanism that aligns the cannula 14 with the first skin contact surface 34 or numerous alternative alignment mechanisms to preferably arrange the cannula 14 generally in parallel with the first skin contact surface 34. Furthermore, the cannula 14 is not necessarily oriented generally in parallel with the first skin contact surface 34 and can alternatively be arranged, such that the tip 14a of the cannula 14 is configured for positioning in the dermal layer of the skin S without being generally aligned in parallel with the first skin contact surface 34.
    [0025] With reference specifically to figure 3A, in the first preferred embodiment, the first and second alignment ramps 36, 38 include an upward sloping surface 36a, 38a, an apex surface 36b, 38b and a downward sloping surface 36c, 38c. The upward sloping surfaces 36a, 28a help guide the cannula 14 through the side opening 22 into the cannula channel 26. The downward sloping surfaces 36c, 38c preferably propel the cannula 14 to a side wall of the cannula 40 in the assembled configuration . The cannula side wall 40 preferably extends generally parallel to the longitudinal geometric axis 18 at least adjacent to the cannula channel 26. The cannula channel 26 is defined by the first skin contact surface 34, the cannula side wall 40 and the alignment wall 42 in the first preferred embodiment and is generally contained in the central portion 24. The cannula 14 is preferably positioned adjacent the side wall of the cannula 40 in the assembled configuration. More specifically, the cannula 14 can be positioned in confrontation with the downward sloping surfaces 36c, 38c of the first and second alignment ramps 36, 38 and with the cannula side wall 40 in the assembled configuration. Thus, the first and second alignment ramps 36, 38 and the side wall of the cannula 40 align the cannula 14 generally in parallel with the first skin contact surface 34 in the assembled configuration and generally center the cannula 14 along the longitudinal geometric axis 18 in the assembled configuration. However, the cannula 14 is not limited to being aligned and centered using the first and second alignment ramps 36, 38 and the side wall 40 as described above and can be otherwise aligned and guided by the adapter 10, such that the tip 14a is positioned on the dermal layer of the patient's skin in the injection configuration. In addition, the cannula 14 is not limited to being generally coaxial with the longitudinal axis 18 in the assembled configuration and can be misaligned or slightly inclined with respect to the longitudinal axis 18, as long as the tip 14a is generally positioned on the dermal layer in position injection.
    [0026] With reference to figure 4, the first skin contact surface 34 is spaced a relatively consistent distance from the distal portion of the cannula 14. The first skin contact surface 34 is also generally continuous between an area adjacent to a tip 14a of the cannula 14 and an area adjacent to the edge of the channel 26a in the assembled configuration. In the first preferred embodiment, the syringe 12 can generally be coaxial with the longitudinal axis 18 and the distal portion of the cannula 14 is tilted slightly upwards and away from the longitudinal axis 18 to be in alignment generally parallel with the first contact surface. with skin 34 in the assembled configuration. The distal portion of the cannula 14 is preferably spaced at a distance from the opening of the cannula X from the first skin contact surface 34. The distance from the opening of the cannula X is at least preferably two tenths of a millimeter (0.2 mm) and it can be within a range of two tenths of a millimeter to two millimeters (0.2 - 2 mm). However, the distance from the opening of the cannula X is not limited to be in this range and can be understood from almost any distance that allows the tip 14a of the cannula 14 to be positioned in the dermal layer of the patient's skin S in the injection position. In the first preferred embodiment, the distance from the opening of the cannula X is approximately fifty-five hundredths of a millimeter (0.55 mm). In addition, a more preferred range for the cannula X opening distance is approximately four tenths of a millimeter to eight tenths of a millimeter (0.4 - 0.8 mm). The cannula 14 of the first preferred embodiment can be a measuring cannula 27 and the distance from the opening of the cannula X between the first skin contact surface 34 and the outer diameter of the cannula 14 can be fifty-five hundredths of a millimeter (0 , 55 mm) or larger, generally resulting in the tip 14a of the cannula 14 being positioned within the dermal layer in the injection position. The distance from the opening of the cannula X can be impacted by the orientation of the cannula 14 (lancet up or lancet down), cannula measurement 14, expected location of the patient's injection and numerous other factors that can be considered by the designer.
    [0027] In the first preferred embodiment, the tip 14a of the cannula 14 is positioned approximately one and a half to ten millimeters (1.5 - 10 mm) along the longitudinal geometric axis 18 of the defined demarcation plane 27 where the cannula 14 extends over the channel edge 26a. The demarcation plane 27 intersects and is generally perpendicular to the longitudinal geometric axis 18. In the first preferred embodiment, the tip 14a of the cannula 14 is positioned distally beyond the demarcation plane 27, defined where the cannula 14 extends over the edge of the cannula. channel 26a, in an exposed length L1. The exposed length L1 is not limited to one and a half to ten millimeters (1.5 - 10 mm) described above and can be of almost any length that allows the insertion of the tip 14a into the dermal layer of the patient's skin S in the injection configuration. In a more preferred range, the exposed length L1 is approximately two and a half to seven millimeters (2.5 - 7 mm) and in a more preferred range, the exposed length Li is approximately two and a half to four millimeters (2.5 - 7 mm) 4 mm). In the assembled configuration, the exposed length Li is preferably predetermined during the design of the adapter 10 and the cannula 14 generally does not move or slide relative to the adapter in the assembled configuration. Thus, once the syringe 12 is engaged with the adapter 10 of the first preferred embodiment, the exposed length L1 generally does not change and the cannula 14 and the associated syringe 12 do not slide in relation to the body 16, the central portion 24 and the distal protuberance 30.
    [0028] The distal protuberance 30 of the first preferred embodiment is generally clear or transparent, at least in the distal direction to the distal tip 32 in relation to the demarcation plane 27 and is generally cloudy or opaque in the proximal direction of the demarcation plane 27. The central portion 24 and the rest of adapter 10 are also preferably cloudy or opaque. The provision of a generally transparent distal protuberance 30, at least in the distal direction of the demarcation plane 27, and a distal protuberance 30 and adapter 10 generally opaque in the proximal direction of the demarcation plane 27 provides a visual cue to a medical professional or user who the cannula 14 is penetrating the skin S during the injection and that the skin S is in confrontation with the first skin contact surface 34 in the injection position. The distal portion of the cannula 14 may appear to disappear or be completely positioned under the skin S in the injection position due to the distal protuberance 30 generally transparent in the distal direction in relation to the demarcation plane 27 and cloudy or opaque in the rest of the adapter 10, since the proximal portion of the cannula 14 which is positioned proximal to the demarcation plane 27 can be obscured by the opaque or cloudy portions of the adapter 10. This disappearance of the cannula 14 also provides a visual clue for the medical professional or user that the cannula 14 penetrates into skin S for a sufficient distance, and additional pressure or insertion force is not required to insert the cannula 14. This visual cue can be particularly useful for "heavy-handed" medical professionals or users who can apply excessive pressure to the injection position and potentially make the skin S clump between the first skin contact surface 34 and the cannula 14, which p it could damage the cannula 14 or result in the positioning of the tip 14a outside the intradermal layer.
    [0029] The design of the distal protuberance 30 with a generally transparent portion in the distal direction and a generally opaque portion in the proximal direction of the demarcation plane 27 allows the medical professional or the user to visually confirm that the distal portion of the cannula 14 that extends beyond the edge of the cannula channel 26a entered the patient's skin S and skin S is in relatively consistent contact with the first skin contact surface 34, which provides a visual indication to the medical professional or user that the tip 14a of the cannula 14 is positioned in the dermis or dermal layer of the patient's skin S, such that the drug will be injected into the dermis or dermal layer of the patient's skin S for absorption in the patient's body.
    [0030] In the first preferred embodiment, the tip 14a of the cannula 14 is preferably spaced at a suspended length L2 from a distal edge of the distal tip 32. The suspended length L2 is preferably at least one millimeter (1 mm), particularly if the adapter 10 is not includes the distal nozzle 32 facing upwards. In the first preferred embodiment, the suspended length L2 is approximately two to six millimeters (2 - 6 mm). The suspended length L2 provides some safety for users and patients against inadvertent perforation due to exposure to tip 14a, for example, if the medical professional tries to introduce the cannula 14 into skin S usually perpendicular to skin S or inadvertently approaches skin S generally perpendicular to the skin S and also provides a section of the cannula X opening distance relatively constant between the tip 14a and the demarcation plane 27 in the assembled configuration to correctly position the tip 14a on the skin S during insertion. The distance from the opening of the cannula X is preferably consistent between the plane of demarcation 27 and the tip 14 as a result of at least the distal portion of the cannula 14 generally extending in parallel to the first skin contact surface 34. The first Skin contact 34 also preferably extends beyond tip 14a along a generally linear or parallel path, at least for a limited distance before the distal nozzle 32 begins to curve upward and that extended distance can be approximately one to two millimeters (1-2 mm). The suspended length L2 is not limited to the dimensions described above and can have almost any dimension that limits exposure to the tip 14a and facilitates the insertion of the cannula 14 into the skin S at a desired depth of the surface of the skin S. The suspended length L2 also generally prevents perpendicular insertion of the tip 14a of the cannula into the patient's skin S. Attempts to perpendicularly insert the cannula tip 14a into the patient's skin S typically produce imprecise positioning of the tip 14a in the dermal layer and injection of the drug into an undesirable section of skin S.
    [0031] Referring to figures 1 and 2 in the first preferred embodiment, syringe 12 includes a tube 44, a plunger 46 with a piston 46a slidable and sealingly engaged within a hollow cavity 44a of tube 44 and cannula 14. Tube 44a has a generally cylindrical configuration and the hollow internal cavity 44a receives the drug in it. The drug is typically stored between piston 46a and cannula 14 in the hollow internal cavity 44a. Syringe 12 is not limited to the inclusion of tube 44, plunger 46 and cannula 14 and can be comprised of almost any device that is capable of holding the medicine in it, is connected with the adapter 10 and expels the medicine from there or otherwise injects the drug in the dermal layer of the patient's skin S in operation. For example, syringe 12 can be comprised of a pre-filled syringe 12 without a cannula 14, where cannula 14 is associated with adapter 10 (see, for example, figures 11 and 12).
    [0032] In the first preferred embodiment, the adapter 10 includes at least the body 16, the distal nozzle 32, the central portion 24 and the syringe channel 20 which generally extends parallel to the longitudinal axis 18 through the body 16. The body 16 includes the syringe channel 20 and is preferably positioned proximally on the adapter 10 with respect to the central portion 24, which includes the cannula channel 26. The syringe channel 20 receives at least a portion of the syringe 12 and particularly at least a portion of the tube 44 in the assembled configuration. Adapter 10 also includes side opening 22 which preferably extends along the entire length of adapter 10 between the proximal portion 16a and the distal tip 32 or at least to the end of the central portion 24 near the edge of the cannula channel. 26a. The side opening 22 allows for selective insertion of the syringe 12 and cannula 14 with respect to or into the adapter 10. The side opening 22 is preferably slightly narrowed in relation to a maximum diameter of the tube 44, such that the tube 44 is mounted by force or fitted by fitting in the syringe channel 20 during assembly. Plug-in or force-mount tube 44 in syringe channel 20 helps to retain syringe 12 in adapter 10 following assembly. However, tube 44 is not limited to fitting or tightly mounted to the syringe 20 channel and can alternatively be engaged or secured to adapter 10 by pegs, clamping, adhesive union, fixing or otherwise fixing or securing the syringe 12 on adapter 10.
    [0033] In the first preferred embodiment, the syringe channel configuration 20 within the opening 22 defines a narrowed C-shaped clamping section in which the syringe 12 is tightly mounted in the assembled configuration.
    [0034] Referring to figure 5, the distal protrusion 30 has a protrusion width W of approximately three to ten millimeters (3 - 10 mm) to engage the skin S in the injection position (figure 2). The width of the W protuberance is not limited to this range of three to ten millimeters (3 - 10 mm) and can be of almost any width that can be maneuvered by the medical professional or user and encourages the proper placement of the tip 14a in the dermal layer or dermis in the injection position. In the first preferred embodiment, the width of the protrusion W is approximately the same or slightly less than the diameter of the tube 44, but is not so limited. It may be preferable that the width of protrusion W is generally equal to or slightly smaller than the diameter of tube 44 for storage, packaging, maneuverability and general handling of syringe 12 and adapter 10. The width of protrusion W is preferably configured to result in minimizing the forces required during insertion while generally stabilizing the position of the adapter 10 in relation to the skin S during insertion and the injection position. The width of protrusion W of distal protrusion 30 could be narrow relative to tube 44 to integrate other components of the system or it could be larger than tube 44 of syringe 12 to generally maximize stability.
    [0035] Referring to figures 1-3, in the first preferred embodiment, the cannula 14 has a cannula hub 14b which is preferably integrally engaged with a narrowed distal portion 44b of the syringe 12. The cannula 14 is preferably constructed of a metal material which is joined to the cannula hub 14b, which is typically constructed from a polymeric material or plastic. Adapter 10 preferably also includes a positioning wall 48 which is engaged with the narrowed distal portion 44b of tube 44 in the assembled configuration. The interplay of the narrowed distal portion 44b and the positioning wall 48 generally controls the positioning of the tip 14a of the cannula 14 relative to the longitudinal geometric axis 18 to obtain the desired exposed length L1 and the suspended length L2. Thus, adapter 10 is preferably configured for syringes 12 and cannulas 14 having known dimensions, at least with respect to the position of the narrowed distal portion 44b with respect to the tip 14a of the cannula 14, such that the positioning of the tip 14a in relation to the adapter 10 is controllable. The syringe channel 20 is also designed and configured to receive and retain the syringe tube 44 in the assembled configuration.
    [0036] In the first preferred embodiment, adapter 10 includes a collar 50 on the proximal end portion 16a that can be used by a user to manipulate adapter 10. Collar 50 can be used to engage adapter 10 with the user's fingers to maintain the syringe 12 in an appropriate position relative to adapter 10.
    [0037] Adapter 10 also preferably includes a finger grip portion 52 that can be used by the medical professional or nurse to hold and maintain adapter 10 and syringe 12 during use. The finger grip portion 52 allows the medical professional or nurse to hold the adapter 10 and the syringe 12 close to the distal tip 32 to provide control near the tip 14a. During the injection, the medical professional typically handles the adapter 10 and the syringe 12 mounted holding the tube 44 and / or the adapter 10.
    [0038] With reference to figures 11 and 12, in a second preferred embodiment, an adapter 10 'has a configuration similar to the adapter 10 of the first preferred embodiment, but the cannula 14' is attached to the adapter 10 ', the body 16' does not include an opening side for receiving the 12 'syringe, as well as additional structural and functional differences between the first and second modalities. The adapter 10 'of the second preferred embodiment uses the same reference numerals to identify similar aspects in relation to the adapter 10 of the first preferred embodiment and a public symbol (') to specifically identify the adapter 10 'of the second preferred embodiment and its components. In this way, a significant number of aspects of the second preferred embodiment of adapter 10 'are the same or similar to adapter 10 of the first preferred embodiment and aspects that are different in adapter 10' of the second preferred embodiment are emphasized in the description below.
    [0039] In the second preferred embodiment, the cannula 14 'is attached to the adapter 10', such that the tip 14a 'is positioned in relation to the distal protuberance 30' with the predetermined exposed length L1 and the suspended length L2 and typically within the bands described above of the first preferred embodiment. Furthermore, the distance from the opening of the cannula X 'is also predetermined and preferably lies within the preferred ranges described above of the first preferred embodiment. Fixing the cannula 14 'to the adapter 10' generally eliminates the potential misalignment of the cannula 14 'with respect to the adapter 10 and therefore the poor positioning of the tip 14a' with respect to the distal protuberance 30 '.
    [0040] In the second preferred embodiment, adapter 10 'is typically associated with a pre-filled syringe 12' (not shown) without cannula 14 'mounted on it and is typically attached to the proximal end portion 16a' of body 16 'using a conventional Luer . The 12 'syringe can be pre-filled by the manufacturer, filled by the medical professional or user prior to injection or otherwise filled before engaging the 10' adapter with the 12 'pre-filled syringe using a cannula, vial adapter, spike or other mechanism. The syringe 12 'is not limited to being mounted on the body 16' by a Luer in the second preferred embodiment and can otherwise be mounted, attached or attached to the body 16 '.
    [0041] With reference to figures 13-15, in a third preferred embodiment, a 10 ”adapter has a configuration similar to adapters 10, 10 'of the first and second preferred embodiments, but the body 16” is articulable in relation to the central portion 24 ”and the distal protuberance 30 ”, such that the central portion 24” and the distal protuberance 30 ”can be articulated away from the cannula 14” in an aspiration position and articulated for proximity or interlocking with the cannula 14 ”in an assembled configuration. In the third preferred embodiment, the central portion 24 ”and the distal protuberance 30” are articulated in relation to the body 16 ”along a generally arched path indicated by an articulated arrow P. Additional differences between the third preferred modality of the 10” adapter and the other modalities are described below or can generally be identified in the figures. The distal protuberance 30 ”and the central portion 24” are not limited to being articulated in relation to the cannula 14 ”and body 16” and can slide in relation to the cannula 14 ”and body 16” or otherwise move or reposition in relation to the cannula 14 ”and body 16” to alternatively expose the cannula 14 ”and move or reposition to the assembled configuration. The 10 ”adapter of the third preferred embodiment uses the same reference numerals to identify similar aspects in relation to the 10, 10 'adapters of the first and second preferred embodiments and a double quotation mark (“) to specifically identify the 10 ”adapter and its components of the third preferred embodiment. Thus, a significant number of the aspects of the preferred third modality of the 10 ”adapter is the same or similar to the adapters 10, 10 'of the preferred first and second modalities and the aspects that are different in the preferred third modality of the 10” adapter are emphasized in the description below.
    [0042] The body 16 "of the adapter 10" of the third preferred embodiment is generally shaped like a ring with the 20 "syringe channel extended through it. The body 16 "is configured to engage the cannula hub 14b", the narrowed distal portion 44b ", a distal portion of the hub 44" and / or another portion of the syringe 12 "to attach the adapter 10" to the syringe 12 ". The body 16 ”is hinged jointly in the central portion 24” and in the distal protuberance 30 ”by a pivot arm 54”, a pivot shaft 56 ”and a pivot hub 58”. In the third preferred embodiment, the pivot cube 58 ”is formed as a portion of the body 16” and the pivot arm 54 ”and the pivot axis 56” are formed as a portion of the central portion 24 ”and the distal protuberance 30”, such that the central portion 24 ”and the distal protuberance 30” are able to articulate in relation to the 16 ”body and the 12” syringe in an assembled configuration when the 16 ”body is mounted on the 12” syringe. Alternatively, the 16 ”body can be formed as a single mold with the pivot arm 54” and the distal protuberance 30 ”and can include an active hinge (not shown) positioned between the 16” body and the pivot arm 54 ”to allow for articulation between the body 16 ”and the central portion 24” and the distal protuberance 30 ”. Similar to the first and second preferred embodiments, the 30 ”distal protuberance of the 10” adapter is preferably clear or at least partially transparent in the distal direction in relation to the 27 ”demarcation plane, such that the medical professional can visually monitor the 14” cannula and / or the skin S during assembly and use. The body 16 ”is also configured to selectively receive a cap (not shown), such that the cannula 14” can be covered when the distal protuberance 30 ”and the pivot arm 54” are pivoted away from the cannula 14 ”.
    [0043] The 10 ”adapter of the third preferred embodiment is configured for lateral insertion of the cannula 14” into the cannula channel 26 ”, which is generally V-shaped with a wide portion on one side close to the pivot arm 54” and a narrow apex that forms the side wall of the cannula 40 ”opposite the wide portion. The cannula channel 26 ”in V shape guides the cannula 14” to the appropriate position in relation to the distal protuberance 30 ”, similar to the first and second alignment ramps 36, 38 and the side wall of the cannula 40” of the adapter 10 of the first preferred modality.
    [0044] In the third preferred embodiment, the pivot shafts 56 ”preferably have an interference fit with the pivot hub 58”. The ring-shaped body 16 ”is preferably driven into the tube 44” or hub 14b ”during assembly and retains the adapter 10” in relation to the 12 ”syringe in the assembled configuration. The 16 ”body can engage the 12” syringe by forcefully mounted surface contact, male and female bonding, protrusions, bayonet bonding, tightening, fixation, adhesive bonding or almost any mechanism or method that allows the bonding of the body 16 ”with syringe 12”, such that the distal protuberance 30 ”can be articulated to the injection position in relation to the cannula 14”. The cannula 14 ”is captured and aligned with the V-groove of the cannula channel 26” of the central portion 24 ”, such that the cannula 14” is preferably positioned near the narrow apex of the lateral wall of the cannula 40 ”of the third preferred embodiment. A distal section of the cannula 14 ”and the tip 14a” of the cannula protrude through the cannula channel 26 ”below the first skin contact surface 34”. The distal protuberance 30 ”and the pivot arm 54” can be locked in the injection position in relation to the cannula 14 ”after the distal protuberance 30” and the pivot arm 54 ”are articulated to the injection position following the aspiration of the medication, but it is not limited to being locked or otherwise stuck in the injection position.
    [0045] The V-groove of the 26 ”cannula channel can also be arranged such that the wide portion of the 26” cannula channel of the V-groove is positioned opposite or facing away from the 30 ”distal protuberance. In such a configuration, the wide portion or channel entrance of the 26 ”cannula of the V-groove extends through the second skin contact surface 28”, such that the first skin contact surface 34 ”is pushed along an arc towards or away from the top of the cannula 14 ”when the central portion 24” and the distal protuberance 30 ”are articulated to and from the injection position. That is, in that alternative arrangement of the 10 ”adapter of the third preferred embodiment, the wide channel portion of the cannula 26” in the shape of the V-groove is generally positioned along a surface of the central portion 24 opposite the distal protuberance 30 ”or in a bottom surface of the 10 ”adapter. In contrast, in the third preferred embodiment, the wide or open channel portion of the 26 ”cannula of the V-groove is located on one side of the central 24” portion.
    [0046] With reference to figures 16 and 17, in a fourth preferred embodiment, an adapter 10 ”'has a configuration similar to adapters 10, 10', 10” of the first, second and third preferred embodiments, but the adapter 10 ”'is integrally formed with or is fixedly attached to the 12 ”syringe”. The 10 ”adapter of the fourth preferred modality uses the same reference numerals to identify similar aspects in relation to the 10, 10 ', 10” adapters of the first, second and third preferred modalities and a triple tick symbol (“') to identify specifically the 10 ”adapter and its components of the preferred fourth modality. Thus, a significant number of aspects of the preferred fourth modality of the 10 ”adapter are the same or similar to the 10, 10 ', 10” adapters of the first, second and third preferred modalities and the aspects that are different in the fourth preferred modality of the 10 ”adapter are emphasized in the description below.
    [0047] The 10 ”adapter of the fourth preferred embodiment is generally designed for a pre-filled arrangement, with the 12” 'syringe permanently attached to or fully formed with the 10 ”adapter and packaged in a sterile package for transportation and / or storage. The adapter 10 ”‘ preferably has a diameter in the central portion 24 ”‘ which is approximately the same as the diameter of tube 44 ”’ of syringe 12 ”‘, but is not limited in such a way. In addition, the 16 "‘ adapter 10 ”‘ body of the preferred fourth embodiment is permanently joined or integrally formed with the 44 ”’ tube of the 12 ″ syringe. The diameter of the central portion 24 ”'and / or of the body 16”' may be smaller or larger than the diameter of the tube 44 ”'or may otherwise be formed as an oval, square, rectangular or other shape that is formed with or permanently engaged with the 12 ”syringe tube. For example, the 10 ”adapter of the fourth preferred embodiment can be comprised of a fully molded polymeric material that is formed at the same time as the 44” tube, can be mounted on the 44 ”'tube of the 12” syringe, which it may be constructed of glass material, or it may otherwise be permanently attached to the 12 ”'syringe during the manufacture of the 12”' syringe.
    [0048] The 10 ”'adapter and the 12”' syringe that are integrally formed or assembled during the manufacturing process allow the manufacturer to define the alignment of the cannula 14 ”'with the first skin contact surface 34”', the distance from the opening of the cannula X ”', the entire flow path of the fluid between the tube 44”' and the tip 14a ”'(preferably limiting or shortening this flow path) and the position and orientation of the cannula 14”' in relation to the axis 18 ”longitudinal geometric pattern. The fully formed or assembled 10 ”adapter of the fourth preferred modality also allows the manufacturer to maintain the sterility of the 14” cannula and 10 ”adapter section in contact with the skin from the moment the 10” adapter and syringe 12 ”'are initially packaged until the 10”' adapter and the 12 ”'syringe are removed from the packaging, which preferably occurs just before the injection process. The 10 ”adapter of the fourth preferred embodiment still allows the manufacturer to seal the fluid path from tube 44” 'to tip 14a ”', such that the drug does not leak from the flow path due to defective components for errors during assembly in the field by the user. The manufacturer is also able to predetermine the orientation of the tip 14a ”‘ cannula 14 ”‘ in a lancet orientation upward, a lancet orientation downward or in almost any orientation that is deemed advantageous by the manufacturer or preferred by the user.
    [0049] In the fourth preferred embodiment, the 10 ”adapter also preferably includes a 60” elastomeric cap that can be removably mounted on the 10 ”adapter and on the 44” tube of the 12 ”syringe or on the hub 14b” 'for generally protect the 10 ”adapter during transport and storage, seal the tip 14a” 'of the cannula 14 ”' to keep the medication in the 44” tube and to generally maintain the sterility of the 10 ”adapter until the medical professional or another user is prepared to give the patient an injection. The 60 ”'elastomeric cap is preferably constructed of an elastomeric material that is able to adapt to, engage and seal in the 44”' tube and other portions of the 10 ”'adapter to seal the medication in the 44”' tube and generally maintain the sterility of the 10 ”adapter when the cap 60” is attached to the 12 ”syringe. Cap 60 ”'is preferably forcibly mounted on syringe 12”' in a mounted configuration (not shown), such that tip 14a ”'is positioned within the material of elastomeric cap 60”' to block the flow path for off tip 14a ”'and generally keep the medication in tube 44”' or generally prevent medication from leaking when cap 60 ”'is attached to the 10” adapter.
    [0050] The diameter of the cap 60 ”’ can exceed that of the tube 44 ”‘, it can be relatively the same or it can be relatively smaller, depending on the manufacturing equipment and / or user and design preferences. The cap 60 ”'is preferably mounted on the syringe 12”' and adapter 10 ”'pushing the cap 60”' over and into the tube 44 ”', such that the cap 60”' engages and is compressed around a portion from the distal end of the tube 44 ”'and the tip 14a”' is positioned inside the elastomeric material in a distal head portion 60a ”'of the cap 60”'. The preferred force mounting of the cap 60 ”'on the tube 44”' and the incorporation of the tip 14a ”'in the material of the distal head portion 60a”' generally improve the sterility or maintain the sterility of the 10 ”adapter until the cap 60 ”'is removed from the 10” adapter before injection of the medication into the patient. Tip 14a ”'is generally held in the distal head portion 60a”' in a storage position until just before injection of the drug into the patient to reduce the likelihood that the 10 ”adapter and / or cannula 14” 'will become contaminated and that the medicine leaks from the 12 ”syringe”. The 60 ”cap is not limited to being comprised of a single elasomeric component and can be comprised of multiple components that are elastomeric or a combination of relatively rigid and elastomeric materials that generally cover and protect the 10” adapter during storage , transportation and before the injection process. For example, the cap 60 ”′ may be comprised of an elastomeric material positioned within a generally rigid polymeric shell which functions in a similar manner to the 60” ’elastomeric cap described above.
    [0051] Referring to figures 1-10, in operation, syringe 12 is supplied pre-filled or the drug is aspirated into syringe 12 from a vial (not shown). The syringe 12 can be separated from the adapter 10 to draw the medication into the syringe 12 and a different cannula 14 can be used to draw the medication into the syringe 12 than is used to inject the medication into the patient. For example, a relatively large cannula 14 can be used to aspirate the drug into tube 44 and the relatively large cannula 14 can be replaced with a smaller cannula 14 for injection. Alternatively, the central portion 24 and the distal protuberance 30 can be pivotally mounted on the tube 44 and / or hub 14b and the cannula 14, such that the central portion 24 and the distal protuberance 30 can be pivoted away from the cannula 14 during aspiration of the medicine from the vial into the syringe 12 and then hinged back to the assembled configuration for the injection procedure.
    [0052] After the medication is in the syringe 12, the syringe 12 is mounted on the adapter 10. Preferably, the syringe 12 is pressure mounted through the side opening 22 into the syringe channel 20 to engage the syringe 12 with the adapter 10. In the assembled configuration, the narrow distal portion 44b is preferably positioned in confrontation with the positioning wall 48 to properly locate the tip 14a with respect to adapter 10. After the narrow distal portion 44b is positioned in confrontation with the positioning wall 48, the cannula 14 generally does not move relative to the adapter 10.
    [0053] In the preferred assembled configuration, at least a portion of the cannula 14 is positioned within the cannula channel 26. During insertion from the side, the cannula 14 is guided into the cannula channel 26 moving along the upward sloping surfaces 36a, 38a of the first and second alignment ramps 36, 38, on the apex surfaces 36b, 38b and along the downward sloping surfaces 36c, 38c. In the assembled configuration, the cannula 14 is preferably positioned in confrontation with the downward sloping surfaces 36c, 38c and the side wall of the cannula 40. The positioning of the needle 14 in this configuration drives the cannula 14 for alignment generally in parallel with the first skin contact surface 34, such that the cannula 14 is spaced from the first skin contact surface 34 by the distance from the opening of the cannula X. The distance from the opening of the cannula X is preferably predetermined, such that the tip 14a is positioned in the dermal layer of the patient's skin S in the injection position.
    [0054] To inject the medication into the patient's skin S, the user can hold the finger grip portion 52 and / or the tube 44 and propel the adapter 10 to mesh with the patient's skin S. The adapter 10 is oriented in relation to the patient's skin S, such that the longitudinal geometric axis 18 is slightly less than in parallel or almost parallel to the user's skin S. Referring specifically to figure 2A, the adapter 10 can be pushed slightly downward towards the skin S and subsequently pushed to or slid along the user's skin S, such that at least the first skin contact surface 34 is intertwined with a surface of the skin epidermis S. When the adapter 10 slides along the skin S, the distal nozzle 32 encourages the relatively smooth sliding of the adapter 10 along the skin S. The cannula 14 generally does not move relative to the adapter 10 during the injection process and the cannula 14 preferably enters the skin S for approximately the entire length exposed Li. The medical professional or user is able to visually inspect the cannula 14 entering the skin S and the surface of the epidermis by contacting the first skin contact surface 34 through the transparent distal portion of the distal protuberance 30, which is demarcated by the preferred transition from transparent to opaque prot distal uberance 30 in the demarcation plane 27. In a fully engaged injection position, the user or medical professional can visually observe that the entire portion of the cannula 14 positioned in the distal direction of the demarcation plane 27 is positioned within the S skin. , the medical professional can observe that the cannula 14 is not visible through the relatively transparent portion of the distal protuberance 30 because the cannula 14 is located within the skin S. During insertion and injection, the medical professional or nurse is also able to see the tip 14a entering the skin S through the distal protuberance 30 generally transparent. In addition, the nurse or medical professional is generally able to see skin S in contact with the first skin contact surface 34 through the distal protuberance 30. In addition, the first and second skin contact surfaces 34, 28 stimulate the positioning of the cannula 14 in relation to skin S to further stimulate the positioning of the tip 14a of the cannula 14 in the dermal layer. In the injection position, the tip 14a of the cannula 14 is positioned in the skin dermis S.
    [0055] After the tip 14a of the cannula 14 is properly positioned on the skin S, the plunger 46 is lowered, thereby propelling the piston 46a to push the medication out of the tube 44, through the cannula 14, out of the tip 14a and inward of the dermal layer. The drug is absorbed into the dermal layer to obtain clinical benefits for the patient.
    [0056] The distance from the opening of the cannula X is designed to position the tip 14a of the cannula 14 on the dermal layer in the injection position (figure 2). Although the epidermis and dermal layer of skin S can vary in thickness, the distance from the opening of the cannula X is designed to result in the positioning of the tip 14a in the dermis or in the lower portion of the epidermis in the injection position for the most common thicknesses of the epidermis and typical S skin dermis. In this way, the combination of adapter 10 and syringe 12 provides a relatively high probability that tip 14a is positioned in the dermis or dermal layer and provides clinical benefit to the patient by applying the drug directly to the preferred skin layer S. Following the injection , syringe 12 and adapter 10 are removed from skin S, typically in the opposite direction of insertion and syringe 12 and adapter 10 are discarded.
    [0057] With reference to figures 1, 11 and 12, in the operation of the second preferred embodiment of the adapter 10 ', the injection and the process are typically the same with the exception that the pre-filled syringe 12 without the cannula 14 is mounted on the end portion proximal 16a 'of the body 16' and the cannula 14 'is attached to the adapter 10'.
    [0058] With reference to figures 13-15, the adapter 10 ”of the third preferred embodiment is mounted on the syringe 12” holding the body 16 ”on the tube 44” and / or on the hub 14b ”’, as described above. The 12 ”syringe can be pre-filled or the pivot arm 54” and the distal protuberance 30 ”can be articulated away from the cannula 14”, such that the medication can be aspirated into tube 44 ”, as would be evident to someone well versed in technique. The pivot arm 54 ", the central portion 24" and the distal protuberance 30 "are then articulated to the cannula 14" until the distal portion of the cannula 14 "is properly positioned in relation to the first skin contact surface 34", preferably coaxially with the 18 ”longitudinal axis. In the injection position, a portion of the cannula 14 "is preferably positioned in proximity to the apex of the cannula channel 26" on the side wall of the cannula 40 ". The drug can then be injected into the patient using the technique described above, which has been described in detail with respect to adapter 10 of the first preferred embodiment.
    [0059] With reference to figures 2, 16 and 17, the use of the 10 ”adapter and 12” syringe of the fourth preferred embodiment typically results in the medical professional initially removing the 10 ”adapter and 12” syringe from a slightly sterile package before the injection process. The patient is prepared for injection and the cap 60 ”’ is removed from tube 44 ”‘ to release cap 60 ”’ from syringe 12 ”’. Sterility of the 10 ”adapter is generally maintained and the fluid path is generally closed, at least until cap 60” 'is removed from tube 44 ”', since cannula 14” 'and adapter 10 ”' are constantly protected by cover 60 ”'. Syringe 12 ”'and adapter 10”' are aligned with the patient's skin S, such that the longitudinal geometric axis 18 ”'is usually parallel to or slightly inclined with respect to the surface of skin S, the first contact surface with skin 34 ”'engages the surface of skin S to align the 12” syringe and adapter 10 ”' with skin S and the syringe 12” 'and adapter 10 ”' are pushed in the distal direction, such that the cannula 14 ”'penetrates the skin S. The tip 14a”' preferably enters the skin S and is guided to the dermal layer or dermis by the configuration of the 10 ”adapter. The medical professional or other user verifies that the cannula 14 ”'is entering the skin S and the surface of the skin S is positioned in contact with the first skin contact surface 34”' visually confirming the position of the cannula 14 ”'and of skin S through the distal protuberance 30 ”'usually transparent during injection. The cannula 14 ”’ may disappear visually from the medical professional and / or from the user’s view in the injection position. When the medical professional or another user verifies the penetration of the 14 ”cannula into skin S and the positioning of skin S in relation to the first skin contact surface 34” ', the drug is injected into the dermal layer or dermis by tightening the plunger 46 ”'to the cannula 14”', thus propelling the medication out of tip 14a ”'and into the patient. Syringe 12 ”’ and adapter 10 ”’ are subsequently removed from the patient’s skin S, generally parallel to the patient’s skin S surface and discarded.
    [0060] It will be verified by those skilled in the art that changes could be made in the modalities described above without departing from the broad inventive concept of the same. Therefore, it is understood that this invention is not limited to the particular embodiments disclosed, but is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.
    权利要求:
    Claims (8)
    [0001]
    Intradermal injection assembly to inject a drug into a dermal layer of the skin, the assembly comprising: a syringe (12) including a cannula (14), with a tip (14a), a hub (14b), a tube (44) and a plunger (46), the tube (44) having a generally cylindrical configuration and a cavity hollow internal adapted to receive the medication in it; and an adapter (10) having a body (16) with a syringe channel (20), a central part (24) with a cannula channel defining a cannula channel edge, a distal protuberance with a distal tip (32), the distal protuberance including a first skin contact surface generally continues (34), a proximal end part and a longitudinal axis (18) extending between the proximal end part and the distal tip (32), where the first skin contact surface is generally continuous (34), in general, parallel to the longitudinal axis (18), a distal part of the cannula (14) being spaced from the first skin contact surface (34) at a distance of cannula opening (X) in the assembled configuration, the tip (14a) of the cannula (14) being positioned distally with respect to the cannula channel edge (26a) in a mounted configuration, in which a lateral opening (22) is extending over an entire length of the adapter (10) usually in pairs allele to the longitudinal axis (18), the opening (22) allowing selective insertion and removal of the syringe (12) from it, CHARACTERIZED by the fact that the adapter (10) comprises an alignment ramp (36) positioned within the cannula channel, where the alignment ramp (36) guides a distal portion of the cannula (14) generally in parallel with the first skin contact surface (34) in the configuration assembled to control the spacing of the cannula (14), in relation to the first skin contact surface (34) so that the tip (14a) of the cannula (14) is configured to position itself in the dermal layer of the skin when the intradermal injection assembly is in an injection position.
    [0002]
    Assembly, according to claim 1, CHARACTERIZED by the fact that the tip (14a) of the cannula (14) is located approximately one to six millimeters (16 mm) from the distal nozzle (32) in the assembled configuration.
    [0003]
    Assembly according to claim 1, CHARACTERIZED by the fact that the distal protuberance is generally transparent distally in relation to a defined demarcation plane where the cannula (14) crosses the cannula channel edge (26a) in the assembled configuration , the distal protuberance and the central portion (24) of the adapter (10) being generally opaque proximally to the demarcation plane.
    [0004]
    Assembly, according to claim 1, CHARACTERIZED by the fact that the distal nozzle (32) curves outwards from the longitudinal axis (18).
    [0005]
    Assembly, according to claim 1, CHARACTERIZED by the fact that the cannula (14) is positioned at least partially within the cannula channel in the assembled configuration.
    [0006]
    Assembly, according to claim 1, CHARACTERIZED by the fact that it further comprises: a removable elastomeric cap that can be mounted on the adapter (10) and on a portion of the tube (44) so that a tip (14a) of the cannula (14) is positioned within a distal head portion of the elastomeric cap in a storage position.
    [0007]
    Assembly, according to claim 1, CHARACTERIZED by the fact that the tip (14a) of the cannula (14) is spaced in an exposed length from a demarcation plane defined by the cannula channel edge.
    [0008]
    Assembly, according to claim 7, CHARACTERIZED by the fact that the exposed length is approximately one and a half millimeters to ten millimeters (1.5-10 mm).
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    法律状态:
    2019-01-15| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-07-02| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|
    2019-10-22| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2020-04-22| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-09-24| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 24/09/2020, OBSERVADAS AS CONDICOES LEGAIS. |
    2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/07/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |
    优先权:
    申请号 | 申请日 | 专利标题
    US27156509P| true| 2009-07-23|2009-07-23|
    US61/271.565|2009-07-23|
    US28324909P| true| 2009-12-02|2009-12-02|
    US61/283.249|2009-12-02|
    US34304510P| true| 2010-04-23|2010-04-23|
    US61/343.045|2010-04-23|
    PCT/US2010/043071|WO2011011697A1|2009-07-23|2010-07-23|Intradermal injection adapter|
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