Adapter and syringe

Abstract

A syringe assembly includes a syringe barrel having a proximal end and a distal end, a needle hub supporting a needle and coupled to the distal end of the syringe barrel. An adapter is coupled to the needle hub with the needle extending from the adapter to define a length of the needle for injecting a substance into a patient. The adapter has a diameter that is greater than a diameter of the syringe and has a distal face and a proximal face, the distal face being shaped and dimensioned to control a depth of penetration of the needle into the patient, the proximal face forming a finger grip.

Description

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 042,495, filed June 22, 2020, which is incorporated herein by reference. Technical Field

[0002] The present invention relates to a syringe assembly with an adapter for providing a skin contact surface for control, for limiting the depth of needle insertion, for manipulating the syringe during aspiration, and for modifying the length of the exposed portion of the syringe needle. Background Technology

[0003] Needle lengths in the range of 4mm to 6mm are typically used for administering medications to patients. Some devices have needles long enough to be inserted into containers or vials and allow for proper aspiration. The needle length requires that it pierce the diaphragm in the vial in a straight line to ensure penetration and reduce the risk of needle bending.

[0004] The depth of needle insertion into a patient's skin depends primarily on the characteristics of the needle itself, rather than the characteristics or structure of the needle support. Needle insertion into the patient's skin generally occurs in three phases that affect the injection depth. The first phase corresponds to the initial contact between the needle and the skin, where the tissue deforms without piercing the skin surface. The second phase refers to the piercing of the skin and the relaxation of the skin when the needle insertion force ceases. The third phase is the withdrawal of the needle and the outward pulling or stretching of the skin during withdrawal.

[0005] Some needle lengths, such as approximately 4 mm to 6 mm, are suitable for injecting medication into a designated target depth in the subcutaneous region. This invention provides a structure that allows the needle to be continuously inserted to the desired target depth. One example of a delivery device includes a cannula supported on an axial column extending from a hub. This column forms a narrow section and a relatively wide base that does not contact the skin during injection. In other devices known in the art, the distal side of the hub, positioned against the injection site, can be relatively large and may have a slight taper at its edges. When the cannula is inserted at an angle relative to the patient's skin surface, the edges of the hub can engage the skin.

[0006] Various injection devices have been manufactured in which the support structure does not contact the skin during injection or needle withdrawal. Other devices have been proposed in which the end face of the device is positioned to contact the skin surface to limit the depth of insertion into the patient.

[0007] Injections can be performed in the intradermal, subcutaneous, and intramuscular (IM) regions of the skin. For many types of injectable medications, including insulin, the SC region is the preferred injection site.

[0008] While existing devices are generally suitable for their intended use, there is still a need for improved devices to control the insertion depth of the cannula in order to deliver drugs or medications to selected target areas. Summary of the Invention

[0009] This disclosure relates to a syringe assembly having a syringe barrel and a needle for injecting a drug into a patient. In one embodiment, the syringe includes a distal end having a shape and configuration for controlling the depth of needle insertion into a surface (such as the patient's tissue) using the user's insertion force. The distal end of the syringe may also have a shape and configuration to facilitate manipulation of the syringe by the user during needle insertion through a diaphragm in a vial for filling and aspiration.

[0010] In one embodiment, the syringe assembly includes a syringe barrel and a needle or cannula extending from a distal end of the syringe barrel. The syringe barrel includes a distal end or end member forming the distal end of the syringe barrel, wherein the cannula or needle extends axially for injecting a drug into a patient. The distal end includes an axial end face for contacting the patient's skin when the needle is inserted into the patient's skin. The axial end face is configured to provide dimensions and contours for controlling the depth of needle insertion into the skin by controlling the stretching and contouring of the skin surface during injection. The distal end of the syringe barrel may have a radially extending flange or other members that allow the user to force the needle through a diaphragm member of the vial to fill the syringe. The flange may help the user axially align the needle with the opening of the vial and orient the needle perpendicular to the surface of the diaphragm member to prevent the needle from being inserted into the diaphragm member at an angle.

[0011] In one embodiment, the syringe includes a syringe barrel and a plunger, wherein the syringe barrel has a distal end supporting a needle or cannula. The distal end of the syringe barrel has an axial surface with a diameter larger than that of the syringe barrel. The distal end may have a convex or concave distal surface forming a skin contact surface. The convex profile has a central post surrounding the base of the needle, the central post protruding axially from the outer peripheral surface of the axial surface. The concave profile has a central post surrounding the base of the needle, the central posts being spaced proximally to the outer peripheral surface.

[0012] In another embodiment, the syringe includes a syringe barrel having a distal end with an axial face having a protruding profile having an annular recess surrounding a needle. The annular recess is spaced radially outward from the needle and radially inward from the annular outer peripheral surface of the axial face.

[0013] In one embodiment, the syringe has a distal side having a centrally positioned post supporting the needle and an annular forming portion surrounding and spaced apart from the post to form an annular recess on the distal side. The post has a length extending axially from the annular forming portion to form a surface in contact with the skin surface before the surface of the annular forming portion during injection.

[0014] Another feature of the syringe assembly is that the syringe barrel has a distal end supporting the needle and an adapter member attached to the distal end of the syringe barrel. The adapter member can be integrally formed as a single unit with the syringe barrel, or it can be formed as a separate component attached to the syringe barrel. The adapter member can be connected to the distal end of the syringe barrel by friction or interference fit, or it can be fixed to the distal end of the syringe barrel by bonding (such as welding) or by adhesive.

[0015] These features are essentially achieved through a syringe assembly comprising a syringe barrel having a proximal and a distal end, a hub supporting the needle at the distal end of the syringe barrel, and an axial surface surrounding the needle. The diameter of the axial surface is larger than the diameter of the syringe barrel and has a profile and configuration for contacting the skin to control the depth of needle insertion into the patient's skin.

[0016] The syringe features a syringe barrel having a proximal end and a distal end, a hub supporting a needle and coupled to the distal end of the syringe barrel, and an adapter coupled to the hub of the syringe barrel. The adapter has a proximal end for coupling to the hub of the syringe barrel and a distal end forming a skin contact surface surrounding the needle. The adapter has a distal axial surface surrounding the needle and a protruding structure forming the skin contact surface. In one embodiment, the axial surface of the adapter has an inner central post extending axially and surrounding the base of the needle, and an outer annular portion spaced apart from the post and having a protruding outer peripheral surface. The distal end of the post is spaced distally from the outer portion to be spaced apart from the protruding structure on the distal side of the adapter. The adapter has a proximal surface whose shape and size allow a user to grip the syringe and apply axial force to puncture the diaphragm of a vial to fill the syringe.

[0017] The syringe assembly may also have a syringe barrel with a needle and a distal end, the distal end of which forms a skin contact surface with a recessed configuration. The axial surface of the syringe barrel may have an inner portion surrounding the base of the needle and an outer peripheral surface spaced axially outward relative to the inner portion.

[0018] In another embodiment, the syringe assembly has a syringe barrel having a distal end supporting a needle and an axial surface that forms a skin contact surface during injection into a patient, wherein the axial surface has an inner portion having a flat annular surface surrounding the needle, and an outer peripheral surface having a flat axial surface radially spaced outward from the inner portion and oriented in the plane of the flat surface of the inner portion.

[0019] These and other features of the syringe assembly will become clear from the following detailed description of various embodiments of the syringe assembly disclosed in conjunction with the accompanying drawings. Attached Figure Description

[0020] The following is a brief description of the attached figures, in which:

[0021] Figure 1 This is a perspective view of the syringe assembly in one embodiment;

[0022] Figure 2 yes Figure 1 A side view of the syringe component;

[0023] Figure 3 This is an exploded side view of the syringe assembly;

[0024] Figure 4 This is an exploded 3D view of the syringe assembly;

[0025] Figure 5 This is a side view of a cross-section of the syringe assembly;

[0026] Figure 6 This is an exploded side view of the cross-section of the syringe assembly;

[0027] Figure 7 This is an enlarged side view of the adapter's cross-section;

[0028] Figure 8 This is a side view of the syringe assembly during injection;

[0029] Figure 8A This is a side view of the syringe assembly, showing the diaphragm component of the vial where a finger applies linear force to pierce the vial;

[0030] Figure 9 This is a perspective view of the syringe assembly in the second embodiment;

[0031] Figure 10 yes Figure 9 A side view of the syringe component;

[0032] Figure 11 This is an exploded view of the syringe assembly in the diagram;

[0033] Figure 12 yes Figure 9 End view of the adapter for the syringe component;

[0034] Figure 13 yes Figure 9 A side view of the cross-section of the syringe assembly;

[0035] Figure 14 yes Figure 9 A cross-sectional view of the adapter for the syringe assembly;

[0036] Figure 15 yes Figure 9 A cross-sectional view of the syringe assembly;

[0037] Figure 16 yes Figure 9 A bottom-view perspective view of the adapter for the syringe assembly;

[0038] Figure 17 This is a side view of the adapter, showing the deformation of the skin during injection;

[0039] Figure 18 This is a perspective view of the syringe assembly in another embodiment;

[0040] Figure 19 yes Figure 18 A side view of the syringe component;

[0041] Figure 20 yes Figure 18 An exploded perspective view of the syringe assembly;

[0042] Figure 21 This is an exploded side view of the syringe assembly, showing a cross-section of the adapter;

[0043] Figure 22 yes Figure 18 Top view of the adapter for the syringe component;

[0044] Figure 23 yes Figure 18 An enlarged side view of the syringe assembly;

[0045] Figure 24 This is a side view of the syringe assembly, showing the situation during needle insertion into the skin;

[0046] Figure 25 This is a side view of another embodiment of the adapter hub;

[0047] Figure 26 yes Figure 25 A perspective view of the adapter hub;

[0048] Figure 27 yes Figure 25 Top view of the adapter hub;

[0049] Figure 28 yes Figure 25 A cross-sectional view of the adapter hub;

[0050] Figure 29 yes Figure 25 A perspective view of the adapter hub; and

[0051] Figure 30 This is a front view of the syringe assembly attached to the medicine bottle. Detailed Implementation

[0052] The syringe assembly of the present invention refers to a syringe barrel and needle or cannula for injecting drugs or other substances into a patient. The terms needle and cannula are used interchangeably herein to refer to a thin tubular member having a tip for insertion into an injection site in a subject. The distal direction is the direction toward the injection end of the syringe assembly, while the proximal direction is the opposite direction. The axial direction is the direction along or parallel to the longitudinal axis of the needle and needle hub, while the radial direction is the direction perpendicular to the axial direction.

[0053] The syringe assembly is designed to inject medication into the patient at a selected depth based on the drug and the expected insertion depth. The endodermis of an adult is typically about 2 to 3 mm thick; therefore, intradermal injection depths, measured from the outer surface of the skin, range from approximately 3 mm. The thickness of the subcutaneous layer varies depending on the patient's age, sex, body mass index (BMI), and the body site of injection. The subcutaneous region has an average thickness of approximately 7 to approximately 15 mm. Insulin can be delivered to the subcutaneous region.

[0054] The syringe is suitable for injection methods and for methods of injecting drugs (such as insulin) into a patient. The description of embodiments should not be considered limiting. This disclosure is intended to enable those skilled in the art to practice variations of the described syringe without departing from the scope of the invention. Numerical limitations in the specification and claims are to be understood as being limited by the modifier “about,” such that minor deviations from the equivalent results are within the scope of the invention. Features or limitations of dependent claims disclosed in one embodiment or independent claim may be combined in another embodiment or with different independent claims without departing from the scope of the invention.

[0055] This disclosure is not limited to the structural details and component arrangements illustrated in the following description or shown in the accompanying drawings. The embodiments described herein can be modified, practiced, or implemented in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “including,” “comprising,” or “having,” and variations thereof herein is intended to include the items listed thereafter and their equivalents, as well as additional items. Unless otherwise limited, the terms “connection,” “linkage,” and “installation,” and variations thereof are used broadly herein and include direct and indirect connections, linkages, and installations. Furthermore, the terms “connection” and “linkage,” and variations thereof, are not limited to physical or mechanical connections or linkages. Additionally, terms such as “upper,” “lower,” “bottom,” and “top” are relative and descriptive, but not limiting. These embodiments are not intended to be mutually exclusive, such that features of one embodiment can be combined with other embodiments, provided they do not contradict each other. Those skilled in the art will understand that degree terms such as “substantially,” “about,” and “approximately” refer to and include a reasonable range around and beyond a given value, such as general tolerances associated with the manufacture, assembly, and use of the embodiments. When referring to structure or features, the term "substantially" includes most or all of the features present in the structure.

[0056] Referring to the accompanying drawings, the syringe assembly 10 includes a syringe with a syringe barrel 12 having a proximal end 14 and a distal end 16, and an inner lumen containing a drug. The proximal end 14 receives a movable plunger 18 and a stopper 20 for dispensing the substance contained in the syringe barrel 12. The plunger 18 includes a plunger rod and a distal end coupling member for engaging the stopper to the plunger rod. For clarity, the stopper is not shown in some figures, but it will be understood that the plunger 18 will include a stopper during dispensing the contents of the syringe barrel. Figure 1 and Figure 2 As shown, the syringe barrel 12 has a flange 22 at its proximal end that forms a grip for the user's fingers or hand. A mark 24 is provided on the side of the syringe barrel to indicate the volume to be dispensed.

[0057] Reference Figure 3The syringe barrel 12 has a hub 26 at its distal end for supporting the cannula or needle 28. The needle hub 26 extends axially from the distal end of the syringe barrel. In the illustrated embodiment, the needle hub 26 has a generally cylindrical body portion 30 at the distal end of the syringe barrel, and a distal portion 32 spaced distally from the syringe barrel and the body portion 30. In the illustrated embodiment, the hub 26 is integrally formed with the syringe barrel 12 as a single unit. The syringe barrel 12 and the hub 26 can be made of a suitable plastic material and formed as a single unit by a suitable molding process. The needle hub 26 has an axial channel, such as... Figure 5 and Figure 6 As shown, the channel extends axially through the needle hub to support the needle 28, wherein the needle provides a fluid path between the inner cavity of the syringe barrel and the distal injection end of the needle 28. The needle 28 is secured to the hub 26 by adhesive or other mechanisms known in the art.

[0058] The distal portion 32 of the hub 26 extends from the cylindrical portion 30, and its width is smaller than the width or diameter of the cylindrical portion 30. In the illustrated embodiment, the distal portion is formed by a central portion having an axial channel for supporting the needle 28 and radially extending ribs 34 extending outward from the distal portion. In the illustrated embodiment, three ribs 34 are provided, extending radially outward and axially from the cylindrical portion 30. The distal ends of the ribs 34 have inclined axial end surfaces 36 that converge toward the center of the hub and the needle. Figure 3 As shown, the radial dimension of rib 34 is smaller than the outer dimension of cylindrical portion 30 and smaller than the outer dimension of syringe barrel 12.

[0059] In this illustrated embodiment, the syringe assembly 10 includes a distal end member in the form of an adapter 40 coupled to the hub 26. The adapter 40 can be coupled to the hub 26 by a suitable mechanism, such as by adhesive, friction fit, or interference fit. In another embodiment, the adapter 40 can be integrally formed with the hub 26 by a suitable molding process. In one embodiment, the adapter 40 is fixed to the hub 26 and the syringe barrel 12 during manufacturing, such that the syringe assembly is delivered to the end user as a single unit.

[0060] An external needle cover 42 is provided to cover the needle 28 before it is ready for use. In the illustrated embodiment, the outer cover 42 has a generally cylindrical body portion 44, which has a closed distal end 46 and an open proximal end 48. Figure 5 In the illustrated embodiment, the closed distal end 44 is larger than the external dimensions of the body portion 44 to facilitate the user's grip on the outer cover. The body portion 44 has an inner cavity 50 sized for connection with the adapter 40. Figure 6As shown, the inner surface of cavity 50 includes a plurality of annular ribs 52 for providing a frictional engagement with adapter 40. The outer cover 42 may be made of flexible or rigid plastic material and can be attached to or removed from adapter 40 by the user. The outer cover 42 is attached to the adapter to cover the needle before and after use to prevent accidental needle pricks. The outer cover can be removed during use and replaced after use before disposing of the used syringe assembly.

[0061] Needle 28 is typically a stainless steel needle or cannula with a lumen and a sharp tip for injecting the contents of a syringe into a patient. Needle 28 may have a suitable gauge for the intended injection and delivery. The needle may be a gauge 30-36. In one embodiment, needle 28 may be a gauge 32-35. In another embodiment, the needle may be a gauge 34.

[0062] The needle 28 may have an exposed length or effective length suitable for the intended injection to achieve the desired depth of insertion and drug delivery. The exposed length of the needle 28 extending from the distal end of the adapter 40 may be from about 3.5 mm to about 12.7 mm. In one embodiment, the needle has an exposed length of from about 4.0 mm to about 6.0 mm. In another embodiment, the needle has an exposed length of from about 4.0 mm to about 4.1 mm. The needle 28 has a length extending from the lumen of the syringe barrel and through the adapter 40, wherein the exposed portion extending from the adapter has a desired length to penetrate the skin to a selected depth, depending on the drug to be delivered to the patient. The syringe assembly is particularly suitable for use with shorter needle lengths of from about 4.0 mm to about 4.5 mm.

[0063] Reference Figure 5 and Figure 6 The adapter 40 is configured to engage with the hub 26 of the syringe barrel 12 and provide a surface for contact with the patient's skin during injection to limit the depth of needle insertion into the patient's skin. The adapter 40 may be integrally formed with the distal end of the syringe barrel. The adapter 40 has a body portion 54 for engagement with the hub 26 and a distal end portion 56. The distal end portion 56 has a distal surface for contact with the patient's skin during use and a proximal surface.

[0064] like Figure 5 , Figure 6 and Figure 7As shown, the body portion 54 has a generally cylindrical wall with an inner cavity 58 and a proximal end 60. The shape and construction of the inner cavity 58 are for attachment to a syringe. In the illustrated embodiment, the outer surface of the body portion 54 includes longitudinally extending ribs 62 to aid in the user's grip on the syringe assembly during use. The inner cavity 58 has a cylindrical inner surface 64 at the proximal end of the body portion, the dimensions of which are complementary to the outer dimensions of the cylindrical portion 30 of the hub 26. The body portion 54 can be attached to the cylindrical portion 30 by adhesive or welding processes to secure the body portion 54 to the hub 26. In other embodiments, the body portion 54 can be attached to the hub 26 by friction fit or interference fit. Figure 6 As shown, the distal end of cavity 58 has a tapered surface 66 to receive the angled distal end 36 of rib 34. As illustrated, the shape and dimensions of cavity 58 are complementary to the shape and dimensions of the needle hub to provide a secure fit between the adapter and the hub. The needle hub of the syringe may have a different shape and configuration than those shown in the embodiment. The cavity of the adapter has a shape and configuration corresponding to the shape of a particular syringe and needle hub.

[0065] The distal end 56 of the adapter 40 extends axially distally from the body portion 54 and radially relative to the body portion 54 to form a radial flange surrounding the syringe barrel. The distal end 56 has an inner post 68 and an outer annular portion 70 in a ring or circular shape. The outer annular portion 70 is radially spaced outward from the post 68 to form an annular recess 78. The post 68 extends axially distally from the adapter 40 and the outer portion 70 and is oriented towards an axial center. In the illustrated embodiment, the post 68 has a cylindrical sidewall 72, an axially distal end face 74, and an axial channel 76. Figure 6 In the illustrated embodiment, the axial distal end face 76 is substantially flat and oriented in a plane substantially perpendicular to the longitudinal axis of the column. The axial channel 76 is aligned with an axial channel in the hub 26 and with the needle 28 such that the needle 28 extends through the axial channel 76, as... Figure 5 As shown. The axial channel 76 has a diameter that receives the needle 28 and stabilizes the needle to reduce the risk of bending during use. Figure 6 As shown, the axial channel 76 extends from the distal end face 74 to the cavity 58 of the body portion 54 of the adapter 40. In one embodiment, the needle is not fixed to the inner surface of the axial channel.

[0066] An annular outer portion 70 is radially spaced outward from the post 68 to form an annular recess 78 between the post 68 and the annular outer portion 70. The annular recess 78 has a radial width for receiving the outer cap 42 and forming a relief portion where a portion of skin is stretched into the recess when the distal end face of the adapter is pressed against the patient's skin during injection. The post 68 has external dimensions complementary to the internal dimensions of the body portion 44 of the outer cap 42, wherein the outer cap 42 can be frictionally engaged with the post 68.

[0067] The diameter of the annular outer portion 70 is larger than the diameter of the body portion 54, to provide a larger distal contact surface than the hub 26. For example... Figure 6 As shown, the annular outer portion 70 has a distal end face 80 radially spaced outward from the end face 74 of the post 68. The longitudinal length of the post 68 is greater than the longitudinal dimension of the outer portion 70, such that the end face 74 of the post 68 is oriented distally to the end face 80 of the outer portion 70. In one embodiment, the post 68 protrudes distally from the outer portion 70 to provide an axial spacing of approximately 1-2 mm between the axial end face 74 of the post 68 and the axial end face 80 of the outer portion 70. The distal side of the post is oriented distally to the distal side of the annular outer portion to form a substantially convex skin contact surface to control skin stretching and deformation when the distal end is pressed against the skin.

[0068] In this illustrated embodiment, the end face 80 of the outer portion 70 is substantially flat and oriented in a plane parallel to the plane of the end face 74 of the post 68. The outer portion 70 has an annular side surface 82 extending parallel to the longitudinal axis of the adapter 40, and a beveled inclined surface 84 extending between the side surface 82 and the end face 80. The beveled surface 84 may be oriented at an angle of approximately 40° to 50° relative to the longitudinal axis of the adapter 40, and suitably at an angle of approximately 45°. In one embodiment, the beveled surface is a substantially flat inclined surface. Figure 7 In the illustrated embodiment, the side surface 82 has a rounded shape. In other embodiments, the side surface may be a flat surface oriented parallel to the longitudinal axis of the adapter. In this illustrated embodiment, the bottom side of the distal end 56 of the adapter 40 is provided with a plurality of recesses 88 surrounding the end portion.

[0069] The outer portion 70 is sized to contact the skin surface, enabling control over the shape and depth of skin deformation during needle insertion and control over the needle insertion depth. The outer portion 70 may have a diameter and axial length selected to determine the shape and depth of skin deformation when the outer portion contacts the patient's skin. The outer portion 70 defines the external dimensions of the adapter and the skin contact surface of the adapter. The diameter of the annular outer portion 70 ranges from 10.0 mm to 30.0 mm. In one embodiment, the diameter of the outer portion ranges from about 10.0 mm to about 20.0 mm. The axial length between the proximal edge of the bottom of the side surface 82 and the axial end face 74 can range from about 2.0 mm to about 6.0 mm. In one embodiment, the combined axial length of the side surface 82 and the beveled surface 84 is about 3.0 mm to about 5.0 mm.

[0070] The outer portion 70 of the adapter 40 has a proximal side 88 extending from the body portion 54 to the outer edge of the outer annular portion 70. In the illustrated embodiment, the proximal side has a curved, convex shape, the construction and dimensional of which facilitates the user's grip and manipulation of the syringe assembly 10. In this illustrated embodiment, the proximal side includes a plurality of spaced recesses 89 to provide a non-slip surface. The recesses are shown as having a generally rectangular construction, but other shapes may also be provided. The proximal surface has a shape to form a gripping flange for the user when filling the syringe from the vial. Figure 8A As shown, the user can place their index finger 91 and middle finger 93 on opposite sides of the body 54 on the proximal surface while holding the vial in their palm. The fingers can then apply a substantially linear force to the syringe assembly, allowing the needle 28 to pierce the diaphragm 95 of the vial 97 in the axial direction, enabling the needle to pass through the diaphragm for filling and aspiration. The dimensions of the adapter 40 and the outer annular portion 70 help the user align the needle parallel to the axes of the diaphragm and the vial, and facilitate the application of a linear force to the needle. Applying a linear force in the axial direction to the vial and diaphragm ensures that the needle tip penetrates the diaphragm and the inside of the vial to fill the syringe. The linear force reduces the likelihood of the needle entering the diaphragm at an angle, in which case the needle tip may not fully penetrate the diaphragm, preventing the needle from reaching the contents of the vial and thus failing to fill the syringe. The linear force also reduces the likelihood of the needle bending. Users can also utilize the proximal side 88 by placing their fingers on the proximal side to apply insertion force during needle insertion into the patient and to stabilize the syringe during injection.

[0071] During use, remove the outer cover 42 from the end of the adapter 40 to expose the needle. The syringe can be a pre-filled syringe or one that is drawn and filled by the user during use. Figure 8As shown, the syringe is filled by the user holding the vial in their palm and applying insertion force towards the proximal side of the adapter to pull the syringe toward the vial where the needle pierces the diaphragm. Figure 8 As shown, the depth to which the needle 28 is inserted into the patient's skin 86 is the depth to which the adapter surface contacts the skin. The distal surface of the adapter 40 has a certain width and curvature to deform the skin surface under normal insertion force to form a recess with controlled depth and width, thereby controlling the needle insertion depth to a selected depth. The width of the distal surface of the adapter distributes the insertion force over a larger area to limit the depth of skin deformation caused by the distal surface. When the needle pierces the skin, the post 68 of the adapter 40 contacts the skin and forms a recess conforming to the post size. Continuous insertion force causes a portion of the skin to deform and extend into the annular recess until the outer annular portion 70 of the adapter contacts the skin. The flat surface of the outer portion and the angle of the outer edge form a recess in the skin surface and distribute the insertion force over the entire surface area of ​​the skin, limiting the depth of the recess in the skin and limiting the needle insertion depth.

[0072] Another embodiment of the syringe assembly 90 is as follows Figure 9-17 As shown. The syringe assembly 90 includes a syringe barrel 12, an adapter 92, and a needle cover 42. The syringe barrel and needle cover are substantially the same as those in the previous embodiments, and therefore, for clarity and consistency, these components are labeled with the same reference numerals.

[0073] As described in the previous embodiment, the adapter 90 is attached to the hub 28 of the syringe barrel 12. The adapter 90 can be permanently attached to the hub 28 of the syringe barrel by friction fit, interference fit, or by adhesive or welding. The adapter 90 is typically permanently attached to the syringe barrel during manufacturing and delivered to the end user as a single, integrally formed unit. In a further embodiment, the adapter can be molded onto or combined with the syringe barrel to form a single, integral assembly.

[0074] Reference Figure 10-16 The adapter 90 is configured to attach to the hub of the syringe and provides a surface for limiting the insertion depth of the needle 28. Figure 10As shown, the adapter 90 has a body portion 94 at its proximal end and a distal end portion 96. The body portion 94 has a generally cylindrical sidewall 96, with an open proximal end 98 forming an axial channel 100. The axial channel 100 has an inner surface 102, the dimensions of which are complementary to the outer dimensions of the cylindrical portion 30 of the hub 26, for attaching the adapter 90 to the syringe barrel. The inner surface 102 of the axial channel converges at the distal end to form an inclined tapering surface 104. The axial channel 100 converges at the distal end 96 to form a channel 106, the diameter of which is smaller than the diameter of the axial channel 100 and sufficient to allow a needle to pass through, such as... Figure 13 As shown. In this illustrated embodiment, the needle extends through the adapter 90 but is not fixed to the adapter. The axial channel 100 receives the needle to stabilize it and prevent bending during use.

[0075] The distal end 96 is integrally formed with the body portion 94, and its diameter is larger than that of the body portion 94 to define an enlarged skin contact surface during injection. An axial channel 106 of the distal end 96 extends through a central post 108 extending axially from the adapter. An annular outer portion 110 surrounds the post 108 and is radially spaced outward to form an annular recess 112. The outer diameter of the post 108 is complementary to the inner diameter of the needle cap 42 for connecting the needle cap 42 to the adapter 90. As shown, the post 108 has a substantially flat axial surface 118 near the needle 28. The outer peripheral edge of the axial surface 118 is provided with a stepped portion 120 opening into the annular recess 112.

[0076] The annular outer portion 110 in the illustrated embodiment has a substantially cylindrical side surface 114 oriented substantially parallel to the longitudinal axis of the syringe barrel and the adapter. As shown, the side surface 114 is smooth and converges with the body portion 94 with a smooth, continuous curvature. The annular outer portion 110 has an axial surface 116 forming a convex structure, wherein the axial surface 116 is inclined inward toward the post 108 in the proximal direction relative to the adapter 92. The axial surface 116 extends from the outer peripheral edge 122 to the inner edge 124 at the annular recess 112. The outer peripheral edge 122 forms the distal surface of the adapter 92 for initial contact with the patient's skin during injection. Figure 15 As shown, the axial surface 118 of the column 110 is oriented in the same plane as the distal edge of the outer portion formed by the outer peripheral edge 122.

[0077] In the illustrated embodiment, the outer peripheral edge 122 of the axial surface 116 has a rounded profile extending between the axial surface 116 and the side surface 114. The axial surface 116 has a substantially flat, inclined configuration. A plurality of recesses 126 are formed in the axial surface to facilitate skin deformation during injection.

[0078] The adapter 92 has a circular configuration, the diameter of which is sufficient to provide contact with the patient's skin to control the insertion depth of the needle. The diameter of the axial face 116 of the annular outer portion 110 can be from about 10.0 mm to about 30.0 mm. In one embodiment, the diameter of the axial face 116 of the outer portion is from about 10.0 mm to 20.0 mm. The axial distance between the axial face 116 of the outer portion 110 and the axial face 118 of the post 108 can be from about 2.0 mm to about 5.0 mm. In one embodiment, the axial distance between the axial face 116 of the outer portion 110 and the axial face 118 of the post 108 can be from about 2.0 mm to 4.0 mm. The needle can have the same length and specifications as in the aforementioned embodiments.

[0079] like Figure 10 As shown, the adapter 92 has a proximal side 103, which has a substantially convex structure to form a grip for the user. The adapter is large enough to allow the user to place their index and middle fingers on opposite sides of the proximal side 103 to apply an insertion force to the vial, in which the needle can be inserted into the diaphragm in a similar manner.

[0080] In use, the outer needle cap is removed to expose the needle 28 in preparation for injection. The needle 28 pierces the patient's skin surface at the point where the adapter contacts the skin. The outer peripheral edge 122 initially contacts the skin to form a depression within it. The insertion force of the syringe assembly 90 causes the skin to contact the axial face of the needle post and deform into the annular recess 112 and the recess in the axial face of the adapter, as... Figure 17 As shown.

[0081] Another embodiment of the syringe assembly 130 is as follows Figure 18-24 As shown. The syringe assembly 130 includes a syringe barrel 12, an adapter 132, and a needle cover 42. The syringe barrel 12 and the needle cover 44 are substantially the same as those in the previous embodiments; therefore, for clarity and consistency, the components are labeled with the same reference numerals.

[0082] As described in the preceding embodiments, the adapter 132 is coupled to the hub 28 of the syringe barrel 12. The adapter 132 may be permanently coupled to the hub 28 of the syringe barrel by friction fit, interference fit, or by adhesive or welding. In one embodiment, the adapter 132 is permanently attached to the syringe barrel during manufacturing and delivered to the end user as a one-piece integral unit. In a further embodiment, the adapter may be molded onto or combined with the syringe barrel to form a single integrated assembly.

[0083] Reference Figure 20 and Figure 21 The adapter 132 is configured to attach to the hub of the syringe and provides a surface that limits the insertion depth of the needle 28. Figure 21 As shown, the adapter 132 has a body portion 134 at its proximal end and a distal end portion 136. The body portion 136 has a generally cylindrical sidewall 138, with an open proximal end 140 forming an axial channel 142. The axial channel 142 has an inner surface 144, the dimensions of which are complementary to the outer dimensions of the cylindrical portion 30 of the hub 26, for attaching the adapter 132 to the syringe barrel. The inner surface 144 of the axial channel converges at the distal end to form an inclined tapering surface 146. The axial channel 142 converges at the distal end 136 to form a channel 148, the diameter of which is smaller than the diameter of the axial channel 142 and sufficient to allow a needle to pass through, such as... Figure 19 As shown.

[0084] The distal end 136 is integrally formed with the body portion 134, and its diameter is larger than that of the body portion 134 to define an expanded skin contact surface during injection. An axial channel 148 of the distal end extends through a central post 150 extending axially from the adapter. An outer annular portion 152 surrounds the post 150 and is radially spaced outward to form an annular recess 154. The outer diameter of the post 150 is complementary to the inner diameter of the needle cap 42 for connecting the needle cap 42 to the adapter 132. As shown, the post 150 has a convex axial surface 156. The side surface of the post 150 has a substantially cylindrical configuration, wherein the side surface is oriented in a plane parallel to the longitudinal axis of the adapter 132.

[0085] The diameter of adapter 132 is wider at the distal end and converges towards the proximal end of the adapter. For example... Figure 19 and Figure 21 As shown, the outer surface of the adapter 132 has a proximal side having a plurality of annular recesses 160 surrounding the adapter, thereby forming annular ribs 162 to assist the user during injection. The diameter of the adapter is configured such that the proximal surface has dimensions for the user to grip. The annular recesses 160 and ribs 162 form a finger grip, wherein the size of the finger grip allows the user to place their index and middle fingers on opposite sides of the proximal side of the adapter for use in a manner similar to... Figure 8A The illustrated embodiment involves pressing the needle through the diaphragm of the vial to fill the syringe.

[0086] exist Figure 21 In the illustrated embodiment, the outer annular portion 154 of the adapter has a substantially flat distal side 158 that is radially spaced outward from the distal side 156 of the post 150. In this illustrated embodiment, the post 150 extends axially distally relative to the outer annular portion 154. Figure 21As shown, the convex axial surface 156 of the column 150 protrudes distally from the axial surface of the outer annular portion 152. In one embodiment, the entire convex axial surface of the column 150 is oriented distally from the axial surface of the outer annular portion 154, such that a portion of the cylindrical side surface of the column 150 extends distally to the axial surface 158 of the outer annular portion 152.

[0087] The distal side of adapter 132 is sized to form a skin contact surface during injection and to deform the skin surface in a controlled manner to limit the depth of needle insertion. The diameter of the distal side of adapter 132 can be from about 10.0 mm to about 30.0 mm. In one embodiment, the diameter of the distal side of adapter 132 is from about 10.0 mm to about 20.0 mm. The diameter of post 150 can be about one-third of the diameter of the distal side of adapter 132. In one embodiment, the diameter of post is from about 3.0 mm to about 6.0 mm. The distal side of post can protrude from the distal side of the outer annular portion by a distance of about 1.0 mm to about 3.0 mm. The length of the syringe needle is the same as in the aforementioned embodiment. The dimensions of the adapter can also be similar to those in the aforementioned embodiment.

[0088] During use, the syringe is ready for use, and the needle pierces the skin with insertion force. The needle penetrates the surface of the skin at 164, causing the distal side of the adapter to contact the skin and deform the skin surface, thus distributing the insertion force over a sufficiently large area to limit the depth of skin deformation. Figure 24 As shown, the distal side of the adapter is constructed to stretch the skin in a way that helps the needle penetrate and controls the depth of penetration.

[0089] exist Figure 25-30 In another embodiment shown, the adapter is in the form of a hub 160 for connection to the distal end of the syringe. The hub 160 has a similar shape and external configuration to the aforementioned embodiment, having a body portion 162 for connection to the distal end of the syringe and a distal end portion 164 with a width greater than the width of the body portion 162. The outer surface of the end portion 164 is tapered, flaring radially outward toward the distal end 166. The diameter of the end portion 164 provides a proximal surface area to facilitate user manipulation of the syringe as in the aforementioned embodiment.

[0090] like Figure 26 and 28 As shown, the end 162 of the hub 160 has a recessed region 168 surrounded by an annular ring portion 170 extending distally from the end. The annular ring portion 170 defines a distal end 166 and has an inner surface 172 oriented parallel to the axis of the hub 160.

[0091] The body portion 162 in the illustrated embodiment has a cavity 174 shaped and configured to connect with the end of a syringe. In this illustrated embodiment, the cavity 174 has an inner cylindrical surface 176 and an end surface 178. The body portion 162 can be connected to the syringe in a manner similar to that in the aforementioned embodiments. An axial channel 180 extends from the cavity 174 to receive a needle, as in the aforementioned embodiments. The axial channel 180 extends through a post 182. The post 182 has a distal surface 184 recessed relative to the distal end 166 of the annular ring portion 170. The end portion 164 has an annular portion 188 spaced radially outward from the post 182 to form an annular recess 186. In this illustrated embodiment, the annular portion 188 forms the distal surface of a hub and is inclined proximally toward the post 182. Figure 27 and 28 As shown, the annular portion 188 has a plurality of recesses 190. The bottom surface of the annular recess 186 includes a plurality of recesses 192, such as... Figure 28 and 29 As shown.

[0092] Figure 30 A hub 160, connected to the syringe as described in the previous embodiment, is shown. The recessed region 168 and the annular ring portion 170 are sized to receive an end cap 194, which holds the diaphragm within the vial 196 during syringe filling and aspiration. Figure 30 As shown, the annular portion 170 has a certain axial length to stabilize the vial 196. As also shown, the recessed region 168 and the distal surface stabilize the syringe and needle relative to the vial and facilitate the user's piercing of the diaphragm with the needle along an axis parallel to the axis of the vial 196. The hub dimensions can be similar to those of the previously described embodiment. The needle can have a similar length and specifications as in the previously described embodiment.

[0093] The above-described embodiments and advantages are exemplary and not intended to limit the scope of the invention. The description of alternative embodiments is intended to be illustrative and not to limit the scope of the invention. Various modifications, substitutions, and variations will be apparent to those skilled in the art and are intended to fall within the scope of the invention. It is particularly noteworthy that features of different embodiments and claims can be combined with each other, provided they do not contradict each other. Therefore, all such modifications are intended to be included within the scope of the invention as defined by the appended claims and their equivalents.

Claims

1. A syringe assembly, comprising: A syringe having a proximal end and a distal end, a needle hub, and a needle extending from the distal end of the needle hub; and An adapter connected to the needle hub has: an axial channel that receives the needle and defines the effective length of the needle; and a distal end surface surrounding the needle for contacting the patient's skin and limiting the depth of needle penetration when the needle is inserted into the patient's skin. The adapter has an annular proximal side with a curved protruding shape and dimensions forming a grip portion for applying distal forces relative to the syringe assembly.

2. The syringe assembly according to claim 1, wherein, The adapter is fixed to the pin hub.

3. The syringe assembly according to claim 1, wherein, The adapter and the hub seat are integrally formed as a single unit.

4. The syringe assembly according to claim 1, wherein, The diameter of the adapter is greater than the width of the syringe.

5. The syringe assembly of claim 4, wherein, The adapter has a central post and an annular outer portion, the central post having an axial channel for receiving the needle, and the annular outer portion being radially spaced outward from the central post and defining an annular recess between the central post and the annular outer portion.

6. The syringe assembly of claim 5, wherein, The axial length of the central column is greater than the axial length of the outer portion of the ring, thereby the central column extends distally relative to the outer portion of the ring.

7. The syringe assembly of claim 6, wherein, The central pillar has a substantially flat distal side, and the annular outer portion has a substantially flat distal side oriented substantially parallel to the distal side of the central pillar.

8. The syringe assembly of claim 7, wherein, The outer portion of the ring has an inclined outer edge oriented at an angle relative to the distal side of the outer portion of the ring.

9. The syringe assembly of claim 1, wherein, The adapter has a body portion and a distal end portion, the body portion having an open proximal end portion for engagement with the needle hub of the syringe, the distal end portion having a diameter larger than the diameter of the body portion.

10. The syringe assembly of claim 5, wherein, The central pillar has a substantially flat distal side, and the annular outer portion has a substantially flat distal side oriented substantially parallel to the distal side of the central pillar and oriented in the same plane as the distal side of the central pillar.

11. The syringe assembly of claim 5, wherein, The central column has a protruding distal surface.

12. The syringe assembly of claim 11, wherein, The protruding distal surface is oriented distally relative to the distal surface of the outer portion of the annulus.

13. A syringe assembly, comprising: A syringe having a proximal end and a distal end, a needle hub, and a needle extending from the distal end of the needle hub; as well as An adapter fixed to the needle hub has: an axial channel that receives the needle and defines the effective length of the needle; and a distal end surface surrounding the needle for contacting the patient's skin and limiting the depth of needle insertion when the needle is inserted into the patient's skin, the distal end surface of the adapter having a central post surrounding the needle, an outer annular portion radially spaced outward from the central post, and an annular recess located between the central post and the outer annular portion, the adapter having an annular proximal side having a curved convex shape and a dimension forming a grip portion.

14. The syringe assembly of claim 13, wherein, The central post has a distal side with a convex shape surrounding the needle.

15. The syringe assembly of claim 14, wherein, The outer annular portion has a substantially flat distal side.

16. The syringe assembly of claim 15, wherein, The distal side of the central column is oriented distally to the distal side of the distal side of the outer annular portion.

17. The syringe assembly of claim 13, wherein, The outer annular portion has a distal side that forms a concave distal side.

18. The syringe assembly of claim 17, wherein, The distal side of the outer annular portion has an inclined orientation that is inclined proximally relative to the adapter and inwardly inclined toward the annular recess.

19. The syringe assembly of claim 18, wherein, The outer annular portion has an outer peripheral edge defining the distal end of the outer annular portion, and the central post has an axial surface oriented in the same plane as the plane of the outer peripheral edge.

20. The syringe assembly of claim 19, wherein, The central column has a substantially flat distal side.

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