Syringe with patient contacting surface

Abstract

A syringe has a seat for the syringe, the seat having a distal portion facing a patient, the distal portion having a surface for contact with the skin of a subject during an injection. The contact surface is formed by a post supporting the cannula and a distal side of the outer bushing surrounding the post. The axial distance between the distal side of the post and the distal side of the sleeve provides a contact surface having a radius of curvature to control the desired injection. The syringe barrel may have outwardly extending finger-like flanges with haptic members, such as dimples protruding from a proximal side of the flange and recesses in a distal side of the flange.

Description

[0001] This application is a divisional application of Chinese invention patent application No. 201780031077.7, which has entered the Chinese national phase of international application PCT / US2017 / 026510, whose invention name is "Syringe with Patient Contact Surface" and whose international application date is April 7, 2017. Technical Field

[0002] The present invention is in the field of injectable medical devices for delivering medicine or medication to a patient. In particular, the present invention relates to a syringe or pen needle having a needle bearing seat with a patient contacting surface for improving injection performance. The patient contacting surface is configured to promote cannula penetration to a desired depth in the skin. The seat may be integral to the syringe barrel or may be mounted on a medication pen for administering medication, but is not limited to use with such devices. Background Art

[0003] Medication pens for delivering self-administered medications typically include a syringe or pen body that houses a medication compartment and a separate pen needle that can be attached to and detached from the pen body. The syringe or pen needle includes a needle bearing seat having a recess on the proximal side for receiving the pen body and a proximal (non-patient end) needle that enters the medication compartment, the proximal needle typically piercing a septum of a medication cartridge in the pen body. The distal (patient end) of the pen needle assembly includes an angled distal end of the needle that is inserted into an injection site.

[0004] Injections can be made in the intradermal (ID) region, the subcutaneous (SC) region, and the intramuscular (IM) region. For many types of injectable drugs, including insulin, the SC region is preferred for administering injections. See, e.g., Lo Presti et al., Skin and subcutaneous thickness at injecting sites in children with diabetes: ultrasound findings and recommendations for giving injections, Pediatric Diabetes (2012).

[0005] Needles of varying lengths, and with increasing frequency, shorter needles (e.g., 4 mm needles and 5 mm needles), are suitable for achieving a specified target depth of injection into the subcutaneous area. The present invention addresses the need to ensure that the needle is inserted to its target depth regardless of the angle at which a user may approach the injection site with a medication pen.

[0006] In some prior art pen needles, the cannula is supported in a post axially positioned on the seat. The post forms a narrow portion extending distally from a relatively wide portion in which the pen body is received. In other pen needles known in the art, the distal side of the seat that is placed against the injection site may be relatively large and may be provided with a slight taper at the edge. However, when the cannula is inserted at an angle, the edge of the seat engages the skin, thereby interfering with the injection.

[0007] While existing devices are generally suitable for their intended use, there continues to be a need for improved devices for controlling penetration of a cannula for the delivery of a drug or medication. Summary of the invention

[0008] The present invention relates to an injection device, and more particularly to an injection device having a needle hub having a skin contact surface configured to control the penetration depth of a cannula extending from the needle hub. The present invention particularly relates to a needle hub device wherein the contact surface has a height and width that are complementary to each other to control the penetration depth of the cannula by providing a surface area sufficient to control the depth and shape of an indentation in the skin under normal insertion force.

[0009] The syringe of the present invention has a needle hub portion having a central column for supporting a sleeve and an outer sleeve or ring around the column. In one embodiment, the syringe is configured to dispense small doses of content ranging from about 0.3 ml to 0.5 ml, but the capacity can vary depending on the intended use of the injection device. In other embodiments, the syringe can deliver a capacity of about 1 ml to 3 ml. The outer sleeve has a size that contacts the skin surface under a typical insertion force during injection to control the depth of penetration of the sleeve into the skin. The column has a distal end that can be positioned relative to the distal end of the sleeve to provide control of the penetration depth of the sleeve. The column can be positioned substantially flush with the distal side of the sleeve. In other embodiments, the distal end of the column can be axially spaced outwardly from the distal side of the sleeve by a distance so that the distal side of the column and the distal side of the sleeve form a contact surface for contacting the skin and providing a shape and contour to control the deformation of the skin when the sleeve penetrates the skin during use. The size and position of the post relative to the hub provides a skin contacting surface sized to distribute forces across the skin surface to reduce the incidence of the cannula penetrating the skin deeper than intended.

[0010] In one embodiment, the seat of the syringe has a distal surface having a diameter in the range of 2.0 mm to 8.0 mm. The distal surface of the post can extend beyond the distal surface of the sleeve, whereby the distance between the distal surface of the post and the distal surface of the sleeve is about 1.0 mm to about 5.0 mm, typically about 0.3 mm to about 2.0 mm. In other embodiments, the distal surface of the post can protrude from the distal surface of the sleeve by a distance of about 0.3 mm to 0.7 mm. In one embodiment, the distal end of the post can be aligned substantially flush with the distal end of the outer sleeve or recessed relative to the sleeve.

[0011] Another aspect of the present invention is a syringe having a needle hub portion defining a substantially convex skin contacting surface defined by a post and an outer sleeve. In one embodiment, the contacting surface may have a height of about 0.3 mm to 0.7 mm and a thickness of 1 mm. 2 Up to 4mm 2 surface area.

[0012] One feature of the present invention is to provide a syringe having a central post for supporting a cannula and an outer sleeve surrounding the post, wherein the distal end of the post is recessed about 0.3 mm to 0.7 mm relative to the distal surface of the sleeve. The seat can have a diameter or width of about 2.0 mm to 8.0 mm to provide sufficient surface area and has a suitable shape to provide a controlled depth of penetration of the cannula into the skin. The distance between the distal surface of the post and the distal surface of the sleeve allows the patient's skin to enter the recess defined by the recessed post, where the skin contacts the distal surface of the sleeve and the post.

[0013] Compared to conventional syringe hubs, the shape of the syringe hub provides a larger surface area that contacts the patient's injection site, thereby controlling the cannula's penetration depth and reducing the incidence of cannula over-penetration. Greater patient comfort and stability are achieved due to the larger surface area that contacts the skin during injection.

[0014] The various aspects and features of the present invention are basically achieved by providing an integrated syringe, which includes a syringe barrel having an open proximal end configured to receive a plunger and an outlet distal end. A column extends axially from the distal end of the syringe barrel, wherein the column has an axial channel communicated with the cavity of the syringe barrel. A sleeve is received in the axial channel of the column and extends from the distal end of the syringe barrel, wherein the sleeve has an inclined distal end for injection into the skin of a subject. An annular outer sleeve surrounds the column and extends axially from the distal end of the syringe barrel and defines an annular cavity between the column and the sleeve, wherein the sleeve has a distal end positioned relative to the distal end of the column to contact the skin when the sleeve is inserted into the patient's skin.

[0015] Features of the present invention are further achieved by providing a syringe comprising a syringe barrel having a medicament compartment, a proximal end with a plunger, and a distal end with a seat. The seat has an axially extending post having an annular distal side and an axial passageway receiving a cannula and communicating with the medicament compartment. An axially extending annular sleeve surrounds the post and has an annular distal side. The annular distal side of the post and the annular distal side of the sleeve are configured to form a skin contacting surface to control deformation of the patient's skin when contacting the skin with a normal insertion force and to control the penetration depth of the cannula when the cannula is inserted into the patient's body.

[0016] It should be understood that each of the preferred or optional features of the various embodiments may be combined with other features, and features described in combination with one or more specific features may also be combined with one or more other features of other embodiments.

[0017] These and other features of the present invention will become apparent from the following detailed description of the invention, which, taken in conjunction with the annexed drawings, discloses various embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The following is a brief description of the accompanying drawings, in which:

[0019] Figure 1 A standard syringe barrel is depicted having a needle hub portion protruding from the end of the syringe barrel;

[0020] Figure 2 yes Figure 1 A cross-sectional view of a needle hub portion;

[0021] Figure 3 Is a perspective view of the syringe of the first embodiment of the present invention, showing the column and the end of the sleeve is substantially flush;

[0022] Figure 4 yes Figure 3 A partial enlarged perspective view of a syringe seat portion;

[0023] Figure 5 yes Figure 3 A cross-sectional view of a syringe seat portion;

[0024] Figure 6 yes Figure 3 A cross-sectional view of a syringe barrel of FIG. 1 , which deforms the skin by penetration of the cannula;

[0025] Figure 7 is a cross-sectional view of an improved syringe seat;

[0026] Figure 8 is a perspective view of a syringe holder in another embodiment of the present invention;

[0027] Fig. 9 yes Figure 8 A cross-sectional view of a syringe seat portion;

[0028] Fig.10 yes Figure 8 A cross-sectional view of a syringe seat showing deformation of the skin during cannula penetration;

[0029] Fig.11 is a perspective view of a syringe holder in another embodiment of the present invention;

[0030] Fig.12 yes Fig.11 A cross-sectional view of a syringe seat portion;

[0031] Fig.13 is a cross-sectional view showing the insertion of a cannula into the skin and deformation of the skin;

[0032] Fig.14 Is a perspective view of another embodiment of the syringe device;

[0033] Fig.15 yes Fig.14 A side view of a syringe;

[0034] Fig.16 yes Fig.14 A cross-sectional view of a syringe;

[0035] Fig.17 yes Fig.14 Top view of the syringe;

[0036] Fig.18 yes Fig.14 a bottom end view of a syringe; and

[0037] Fig.19 is a cross-sectional side view of a syringe in another embodiment. DETAILED DESCRIPTION

[0038] A syringe is used herein to refer to a device having a drug compartment and a cannula for delivering a drug (e.g., insulin) to a patient. A pen delivery device typically contains multiple doses of a drug and a separate pen needle. The phrase "pen needle" refers to a needle-bearing assembly that can be attached to a drug pen body so that the proximal end of the pen needle assembly enters the drug compartment and the distal end is suitable for insertion into an injection site to perform one or more injections. The terms "needle" and "cannula" are used interchangeably herein. In one embodiment, the cannula can be a member configured to be inserted into an injection site of an object. An example is a cannula with an inclined end for insertion into a patient's body. As used herein, the "distal" direction is the direction toward the injection site, and the "proximal" direction is the opposite direction. "Axial" refers to the direction along or parallel to the longitudinal axis of the needle, and the "radial" direction is the direction perpendicular to the axial direction.

[0039] The location of the subcutaneous layer in the subject's tissue and the desired injection depth vary depending on the patient's age, the body part where the injection is administered, and the like. Therefore, the injection depth must not be considered a critical aspect of the present invention. Generally speaking, the intradermal (ID) layer of an adult has a thickness of about 2 mm to 3 mm, so that the ID injection depth is in the range of about 3 mm or less, which is measured from the outer surface of the skin. The thickness of the subcutaneous (SC) region may vary greatly depending on the location of the injection site on the subject's body and the subject's body mass index (BMI). The average thickness of the SC space is in the range of about 7 mm to about 12 mm, so that the SC injection depth is in the range of about 3 mm to 15 mm. The SC region can be further subdivided into: a superficial subcutaneous (SSC) layer having a thickness of about 1 mm and an injection depth of about 2 mm to about 4 mm, a SC layer having a thickness of about 4 mm, and a depth of about 3 mm to 7 mm; and a deep subcutaneous (DSC) layer, a deep subcutaneous layer having a thickness of about 4 mm and a depth of about 7 mm to about 12 mm. If the injection from the device occurs in the upper region of the subcutaneous space (SSC), it is more likely that the device will result in an ID injection. When the injection from the device occurs in the deeper region of the subcutaneous space (DSC), it is more likely that the device will result in an IM injection. Insulin is preferentially delivered to the SC space. Injection into the ID or intramuscular (IM) space may result in differential absorption of insulin, which is prescribed accordingly.

[0040] The present invention relates to an injection device, in particular to a syringe having a cannula of a predetermined length for penetrating the skin to a predetermined penetration depth. The injection device has a skin contact surface for contacting and deforming the skin when the cannula penetrates the skin to help control the penetration depth at various injection angles relative to the skin surface. The contact surface has a predetermined shape, width and height to control the depth of penetration into the skin to the desired layer of the skin. In one embodiment, the contact surface having a diameter of about 3mm to 4mm provides a surface area or contact area sufficient to prevent deep indentations in the skin around the cannula when the device is pressed against the skin by typical insertion forces during use. The syringe can be, for example, a 0.3ml syringe or a 0.5ml syringe, although oversized sizes can be provided depending on the drug being dispensed.

[0041] Reference Figure 1 and Figure 2, a commonly used syringe barrel 10 has a seat 12 having a post 14 protruding outward from an annular ring 16. The end face of the post is positioned from the outer ring 16 so that only the end of the post contacts the skin during cannula insertion during normal use. The end face of the post is of a size that normally forms a deep indentation in the skin by the post contacting the skin. The deep indentation formed in the outer surface of the skin often causes the cannula to penetrate the skin deeper into the skin layer than the user expects. For example, a 4.0 mm cannula installed in a post having a width of about 1 mm may cause the contact surface to form a deep depression in the skin surface, so that the cannula may penetrate a depth greater than 4 mm and penetrate the deeper layers of the skin, which may cause pain or discomfort to the user. Deeper penetration may also cause the cannula to deliver the drug to a layer of the skin that is less effective in delivering the drug to the patient, and increase the risk of intramuscular injection, especially in pediatric patients.

[0042] In the present invention, the skin contact surface of the syringe seat surrounding the cannula has a width and height, which are configured to provide a larger surface area and greater control over the penetration depth of the cannula. In one embodiment of the present invention, the pen needle device is configured to obtain a cannula penetration of about 4 mm. The skin contact surface is also configured to control the shape, width and depth of deformation of the skin surface when the device is pressed against the skin during cannula penetration. The width is determined as the surface area defined by the peripheral edge that contacts the skin during cannula insertion and during injection or delivery of the drug using normal insertion force. The height refers to the linear distance between the peripheral edge of the contact surface and the proximal end of the contact surface.

[0043] In one embodiment of the present invention, the skin contact surface may have a substantially convex shape, a substantially flat surface, or a concave surface that contacts the skin during cannula penetration and drug delivery. The width or diameter of the contact area may be greater than 3.0 mm, typically about 4.0 mm. In one embodiment, the contact area may have a substantially annular or circular shape. The width of the contact area refers to the diameter or transverse dimension of the peripheral edge, such as Figure 5 As shown by arrow 59. The contact area may be flush or may have a height or depth of about 0.5 mm to about 1.5 mm measured from the peripheral edge of the contact surface to the contact surface of the post.

[0044] exist Figure 3-7 In the illustrated embodiment, the syringe 20 includes a syringe barrel 22 having an open proximal end 24 and a distal end 26 . Figure 5 The inner axial cavity 28 is shown to receive the drug to be delivered to the patient. The open proximal end 24 receives a plunger 30 for dispensing the contents of the syringe. A seat 32 extends axially from the distal end 26 for supporting a cannula 34 and defining a skin contact area.

[0045] Figure 4and Figure 5 The seat 32 shown in FIG. 1 includes a central column 36 extending axially for supporting the sleeve 34. Figure 5 As shown, the post 36 has an axial passage 38 that communicates with the cavity 28 of the syringe barrel 22. The sleeve 34 is mounted in the axial passage 38 and attached by a suitable adhesive 40, such as Figure 5 36. The cannula 34 has a longitudinal length for penetrating the skin to a desired depth. The distal end of the axial passage 38 has a tapered shape that expands outwardly toward the peripheral edge of the post to define a recess 42 for receiving the adhesive 40. In the illustrated embodiment, the adhesive 40 fills the tapered recess 42 so that the axial end of the post is substantially flat and the adhesive does not protrude outwardly from the face of the post 36. In the illustrated embodiment, the distal face 44 of the post 36 has a substantially flat surface oriented in a plane substantially perpendicular to the longitudinal axis of the syringe and the cannula 34. In the illustrated embodiment, the distal face 44 has an annular configuration and has a narrow radial width relative to the diameter of the post 36. The adhesive 40 fills the recess 42 so that the adhesive is substantially flush with the peripheral edge of the post 36 to form a flat distal surface 46 for contacting the skin during insertion of the cannula into the patient.

[0046] The seat 32 includes an annular outer sleeve 48 that forms a sleeve or ring around the post 36. The sleeve 48 is concentric with the post and is spaced radially outward from the post 36 to define an annular recess 50. In the illustrated embodiment, the annular recess 50 extends from the proximal end of the sleeve 48 and the proximal end of the post 36 and extends between the outer surface of the post 36 and the inner surface of the sleeve 48. The radial dimension of the annular recess 50 may be about 0.5 mm to 3 mm, typically about 1.0 mm.

[0047] The sleeve 48 has a distal surface 52 that forms an annular skin contacting surface spaced outwardly from the distal surface of the post 36. In the illustrated embodiment, the distal surface 52 is substantially flat and coplanar with the plane of the distal surface 44 of the post 36. The distal surface 52 has a slightly rounded peripheral edge 53 to provide a degree of comfort to the patient during use. When the cannula is inserted into the patient's body, the distal surface 44 of the post 36 and the distal surface 52 of the sleeve 48 define a skin contacting surface. The distal surface 52 of the sleeve 48 defines the outer dimensions of the skin contacting surface. The sleeve 48 is oriented and sized to contact the patient's skin under typical insertion and injection forces and distribute the force over an area to control the depth of penetration of the cannula into the skin.

[0048] Reference Figure 6, the cannula 34 is inserted into the patient's body to penetrate the skin to a desired depth. The sleeve 48 has a diameter that disperses or distributes the penetration force over a larger surface area of ​​the skin to limit inward deformation or depression of the skin compared to prior art syringes, in which only the post supporting the cannula engages the skin, which forms a deep depression or indentation in the skin, resulting in deep penetration of the cannula. The distal side 44 of the post 36 and the distal side 52 of the sleeve 48 define a substantially flat contact surface to distribute the force over a surface area sufficient to control the depth of the indentation formed by the penetration force, as shown in FIG. Figure 6 shown.

[0049] The initial penetration of the cannula caused by the contact of the seat protruding from the syringe barrel with the patient's skin forms a depression in the skin and establishes the initial cannula penetration depth. Figure 6 The skin surface is shown relaxed so that the skin surface substantially conforms to the shape of the contact surface and limits the penetration depth of the cannula. The present invention relates to the shape, surface area and height of the contact surface to control the penetration depth of the cannula during insertion and application of penetration force to the injection device.

[0050] The cannula in the illustrated embodiment can have a length of about 4.0mm to 6.0mm to penetrate the skin to a desired depth for effective delivery of drugs, particularly insulin. In other embodiments, the cannula can have a length of about 3.5mm to about 8.0mm. In yet another embodiment, the length of the cannula can have a length of about 2.5mm to 6.0mm, and generally has a length of about 4.0mm to 5.0mm. The cannula can be, for example, a 31 gauge or a 32 gauge, but other gauges can also be used. The contact surface of the seat has a width and height to control the deformation and size of the indentation in the skin and to distribute the injection force over a sufficient area, thereby controlling the penetration depth of the cannula. The shape and size of the contact surface distribute the applied pressure when fully engaging the skin surface. The contour combined with the pressure distribution provides improved comfort for the patient. For a given applied force, the height and surface area of ​​the seat and the peripheral surface area affect the degree of compression and relaxation of the tissue.

[0051] The size of the seat can vary depending on the desired penetration depth of the sleeve and the length of the sleeve. The sleeve has an axial length as indicated by arrow 58. The sleeve can have a length of about 5.0 mm to 7.0 mm, with a typical length of about 6 mm. The sleeve can have a diameter of about 4.0 mm to 10.0 mm as indicated by arrow 59, with a diameter generally of about 3.0 mm to 5.0 mm, with a typical length of about 4.0 mm. The diameter of the post 36 can be about 1 / 3 of the outer diameter of the sleeve. The post can have a diameter of about 1.0 mm to 2.0 mm.

[0052] exist Figure 7In another embodiment shown, the post 36 may have a deep recess 54 at the distal end of the axial passage 38 to receive adhesive and secure the sleeve 34 to the post. In this embodiment, the recess 54 is deep enough to allow the adhesive 40 to be recessed relative to the distal end of the post and form a recess 56 around the sleeve 34.

[0053] Figure 8-10 An alternative embodiment of a syringe 60 is shown having a syringe barrel 62 and a seat 64 for supporting a cannula 66. The seat 64 is formed by a central post 68 and an outer sleeve 70. The post 68 has a substantially cylindrical shape as in the previous embodiment, extending axially from the distal end of the syringe barrel. The post 68 has an axial passage 72 for receiving the cannula 66 and an adhesive 74 for fixing the cannula 66 to the post 68. The distal end of the post and the adhesive 74 define a distal face of the post for contacting the skin during insertion of the cannula into the patient's body. In the illustrated embodiment, a rib 69 extends between the central post 68 and the outer sleeve 70 to stabilize the post 68 and the cannula 66. As shown, the rib 69 has a distal end spaced inwardly from the distal end of the post 68.

[0054] The sleeve 70 has a cylindrical shape surrounding the post and extends from the distal end of the syringe barrel to define an annular recess 71. The annular recess 71 can have a radial width of about 1 mm to 3 mm. The sleeve 70 has a distal surface 76 that forms an annular skin contact surface. In the illustrated embodiment, the distal surface 76 has a substantially flat contact surface oriented in a plane parallel to the plane of the distal surface of the post and substantially perpendicular to the longitudinal axis of the cannula. The sleeve has a peripheral edge 77 that is rounded or curved to form a smooth transition between the distal surface and the side surface of the sleeve. The distal surface 79 of the post 68 is recessed relative to the distal surface 76 of the sleeve to form a slight recess 81. As shown Fig.10 As shown, the recess 81 formed by the positioning of the distal surface of the post 68 relative to the distal surface of the sleeve 70 allows the patient's skin 83 to deform into the recess 81 during insertion of the cannula into the patient's skin. The distal surface of the post and the distal surface of the sleeve form a skin contacting surface and have a radius to define a surface area for controlling the depth of the indentation in the skin under the insertion force. Fig.10 Deformation of the skin during cannula insertion is shown, wherein the depression in the skin substantially conforms to the shape of the contact surfaces of the post and sleeve.

[0055] In one embodiment, the axial spacing between the distal surface 76 of the sleeve 70 and the distal surface 79 of the post 68 can be about 1.0 mm to 1.5 mm, generally about 0.3 mm to 0.7 mm. The axial spacing between the distal surface 76 of the sleeve 70 and the distal surface 79 of the post 68 defines the depth of the recess 81. The diameter of the inner edge of the sleeve 70 defines the width of the recess 81.

[0056] Figures 11 to 13 Another embodiment of a syringe 80 is shown having a syringe barrel 82 and a seat 84 supporting a cannula 86. The seat 84 has a central post 88 for receiving the cannula 86 and a tapered recessed end that contains an adhesive 90. As in the previous embodiment, the adhesive fills the recess in the end of the post 88 to form a substantially flat distal surface 92 of the post 88. An outer sleeve 94 surrounds the post 88 to define an annular recess 96 between the post 88 and the sleeve 94. The annular recess 96 can have a radial width extending between the inner surface of the sleeve 94 and the outer surface of the post 88 of about 0.5 mm to 3.0 mm, typically about 1.0 mm.

[0057] exist Fig.12 In the embodiment of the present invention, the axial length of the post 88 is greater than the axial length of the sleeve 94, so that the distal surface 92 of the post 88 is axially spaced outward from the distal surface 96 of the sleeve. Fig.13 As shown, the post 88 is spaced a distance from the sleeve so that the distal surface of the post and the distal surface of the sleeve define a skin contact surface during cannula insertion. The distal surface of the post causes the depth of the indentation to be greater than the depth of the sleeve and provides a smooth, substantially concave curvature of the skin indentation, such as Fig.13 As shown. During insertion and penetration of the cannula using the insertion force normally applied by the patient, the insertion force causes skin deformation. In one embodiment, the distal surface 92 of the post 88 can extend axially from the distal surface of the sleeve 94 a distance of about 0.3 mm to 0.7 mm. In the embodiment shown, the post 88 and the sleeve 94 form a substantially convex curved skin contacting surface. The post 88 can extend a distance from the sleeve to provide, for example, a skin contacting surface having a radius of curvature of about 6.0 mm to 10.0 mm.

[0058] The distal contact surface of the seat can have various configurations to provide desired control over the penetration depth of the cannula. In each embodiment, the distal contact surface has a width or diameter to provide a surface area and height defined by the curvature of the contact surface sufficient to minimize concavity of the skin, which may cause the cannula to penetrate the skin deeper than intended.

[0059] In various embodiments, the post can have a diameter of about 1.0 mm to 3.0 mm, typically about 1.0 mm to 1.5 mm. The post can have a height of about 1.0 mm to 1.5 mm measured from the periphery of the contact surface of the sleeve. The ratio of the diameter (D) of the post and the axial spacing between the distal face of the post and the distal face of the sleeve can be in the range of about 2:1 to about 4:1, typically in the range of about 2.5:1 to 3:1. A larger ratio provides a larger surface area, which provides the patient with increased comfort and greater control of insertion depth.

[0060] Reference Figure 14-18 , shows another embodiment of an injection device, which includes a syringe barrel 100 having a distal end 102 and a proximal end 104. The distal end 102 is similar to Figures 2 to 6 The embodiment of the present invention includes an outer sleeve 106, an inner post 108, and radial ribs 110 extending between the inner surface of the outer sleeve 106 and the radial outer surface of the post 108. Fig.16 As shown, the rib 110 has a distal end 112 that is spaced apart from the ends of the sleeve 106 and the post 108. In this embodiment, the sleeve 106 has an annular distal surface 114 that is oriented in a plane that is substantially perpendicular to the longitudinal axis of the syringe barrel 100. The inner post 108 has an annular distal surface 116 that is oriented in a plane that is substantially perpendicular to the longitudinal axis of the syringe barrel. In the embodiment shown, the distal surface 116 of the post 108 is oriented in the same plane as the distal surface 114 of the sleeve 106. A longitudinal channel 118 extends through the post 108 for receiving and supporting a sleeve 122 and communicating with the inner chamber 120 of the syringe barrel 100. As in the previous embodiment, the sleeve 122 is attached to the post 106 by an adhesive and has the same length and width as in the previous embodiment.

[0061] The proximal end 104 of the syringe barrel 100 has an open end 124 for receiving a plunger (not shown) for dispensing the contents of the chamber 120 in a conventional manner. In the illustrated embodiment, the proximal end 104 of the syringe barrel 100 has an axially extending boss 126 for receiving the operative end of the plunger.

[0062] Flanges 128 extend radially outwardly from opposite sides of the proximal end 104 of the syringe barrel 100 to form a finger grip or finger flange for the user to operate the device and deploy the plunger during use. Fig.15In one embodiment shown, the flanges 128 are substantially identical and mirror images of each other to extend outwardly so that the device can be grasped by the user. In other embodiments, the flanges can be asymmetrical, with different shapes, sizes and orientations to provide a desired tactile feel to help the user grasp and manipulate the device. The flange 128 has a distal surface 130 and a proximal surface 132. In the embodiment shown, the flange 128 is bent away from the distal end of the syringe barrel 100 to form a substantially concave surface of the proximal surface 132. In an alternative embodiment, the flange can be bent in the opposite direction toward the distal end of the syringe. As shown, the flange 128 has a curvature to provide an ergonomic grip and a unique feel to increase the compliance with the user's finger comfort of use. The ergonomic shape and configuration of the flange 128 provides increased comfort and tactile confirmation, which makes it easier to hold and handle the syringe for people with dexterity problems (such as arthritis and neuropathy that may occur in diabetics). In other embodiments, one or both flanges can be bent toward the distal end or can be straight and substantially flat.

[0063] In one embodiment, the flange 128 is provided with a tactile structure to assist the user during the deployment of the plunger and the delivery of the substance. The tactile structure can be located on one or both flanges and on either or both of the distal surface and the proximal surface. In the illustrated embodiment, a dimple 134 is formed in the flange 128 to extend from the proximal surface of the flange. In the illustrated embodiment, the dimple 134 is oriented toward the outer edge 136 of the flange 128, thereby forming a smooth curved portion 128 between the dimple 134 and the sleeve 126. In other embodiments, the dimple can be positioned in the center or other position of the flange surface or multiple flange surfaces. In the illustrated embodiment, the dimple 134 has a substantially convex dome-shaped teardrop shape, wherein the outer edge 138 of the dimple is formed at the outer edge 136 of the flange 128. Alternatively, the dimple can have other shapes, such as an inverted rounded or oval shape. The width, length, and height of the dimple 134 are sufficient to provide a tactile sense to help the user locate and hold the syringe. In other embodiments, the dimples or other tactile members may be spaced inwardly from the ends of the flanges and may be disposed in other suitable orientations. In one embodiment, the dimples may extend the width or length of the flanges and be disposed on one or both surfaces of the flanges.

[0064] Ridges 140 may be provided on the surface of the dimple 128 to provide additional tactile feel. In the illustrated embodiment, the ridges extend on the outer surface of the dimple 134 and are positioned toward the outer edge relative to the convex surface of the dimple 134. The ridges may be oriented to extend radially outward on the outer and / or inner surfaces of the dimple. In other embodiments, recesses or other tactile features may be provided on the dimple in lieu of protruding ridges.

[0065] The dimple 134 forms a recessed depression 142 on the distal surface 130 of the flange 128, such as Fig.18 As shown. The recess 142 may also have one or more ridges or recesses in the surface to provide a tactile feel. A substantially U-shaped open portion 144 is formed along the outer edge to form a recess along the outer edge 136 to provide a tactile feel for the user. A protruding pawl 146 is formed in the concave surface of the recess 142, and the pawl protrudes toward the distal end of the syringe barrel 100. As shown in FIG. Fig.16 and Fig.18 As shown, ridges 148 can be formed near pawls 146 to extend over the width of the recessed recess 142. Pawls 146 and ridges 148 provide additional tactile sensations for the user to help hold and position the syringe barrel. In other embodiments, the ridges can be arranged to extend over the entire surface of the proximal surface, the distal surface, or both the distal surface and the proximal surface.

[0066] In the illustrated embodiment, the dimples protrude from the proximal surface. In alternative embodiments, the dimples may protrude from the distal surface to form a recess on the proximal surface. In other embodiments, other tactile formations or features may be provided on the proximal and / or distal surfaces to assist the user in positioning and manipulating the syringe. Fig.19 In another embodiment shown, flange 128 is bent toward the distal end of the syringe. For consistency, Fig.19 Elements of the embodiments are identified by the same reference numerals. Fig.19 In the embodiment of the present invention, dimple 140 is shown as protruding from the distal surface of the flange toward the distal end of the syringe. Recess 136 is shown as being formed on the proximal surface of the flange. In other embodiments, dimples or other tactile members may protrude from the proximal surface of one or both flanges or from the distal surface of one or both flanges. In a similar manner, one or more recesses may be formed on the proximal surface, the distal surface, or both the proximal and distal surfaces on one or more flanges.

[0067] The dimple 134 in the flange 128 is shown in conjunction with an embodiment in which the axial length of the inner post 108 is substantially the same as the axial length of the sleeve 106. The dimple 134 may also be included in Figure 3-7 In the embodiments and Figure 8-10 In the embodiment, the axial length of the column 68 is less than the axial length of the sleeve 70, and the recess may also be included in Figure 11-13 In the embodiment described above, the axial length of the post 88 is greater than the axial length of the sleeve 94 to provide a desired tactile feel to the syringe during use.

[0068] The above description of the preferred embodiments should not be considered to limit the present invention, which is defined by the appended claims. The present disclosure is intended to enable a person of ordinary skill to implement variations of the present invention described without departing from the scope of the present invention. Numerical limitations in this specification and claims should be understood to be limited by the modifier "about", so that minor deviations that produce equivalent results are within the scope of the present invention. Features or dependent claim limitations disclosed in conjunction with one embodiment or independent claim may be combined in another embodiment or with different independent claims without departing from the scope of the present invention.

Claims

1. An integrated syringe, comprising: a syringe barrel having an open proximal end and an outlet distal end, the open proximal end being configured to receive a plunger; a post integrally formed with the syringe barrel and extending axially from the outlet distal end of the syringe barrel, the post having a distal end face and an axial passage communicating with the cavity of the syringe barrel; a cannula received in the axial passage of the post and extending from the distal face of the post of the syringe barrel, the cannula having a length of 3.5 mm to 8.0 mm and having a beveled distal end for injection into the skin of a subject; an annular outer sleeve formed integrally with the syringe barrel and surrounding the post and extending axially from the outlet distal end of the syringe barrel and defining an annular recess between the post and the annular outer sleeve, the annular outer sleeve having a distal end face positioned at a distance relative to the distal end face of the post to contact the skin of a patient when the cannula is inserted into the skin of the patient, whereby the distal end face of the annular outer sleeve and the distal end face of the post form a radius of curvature The syringe barrel, the column and the annular outer sleeve define an integrated one-piece syringe, wherein the distal end surface of the column is axially spaced apart from the distal end surface of the annular outer sleeve by a distance of 0.3 mm to 0.7 mm, and wherein the ratio of the diameter of the column to the axial spacing distance defined between the distal end surface of the annular outer sleeve and the distal end surface of the column is 2:1 to 4:1, The syringe barrel further comprises at least one flange, the flange extending radially outward from the proximal end of the syringe barrel for a user to grasp, the flange having a proximal surface with at least one tactile member and / or having a distal surface with at least one tactile member, wherein the tactile member on the proximal surface of the flange is a dimple protruding outwardly from the proximal surface, and wherein the tactile member on the distal surface is a recess, wherein a substantially U-shaped open portion is formed along the outer edge of the flange, and Wherein, a protruding ridge is provided on the surface of the dimple or the recess, and the ridge extends in a curved manner on the surface of the dimple or the recess, thereby providing an additional tactile feeling.

2. The integrated syringe according to claim 1, wherein: The distal end face of the post is spaced axially outwardly from the distal end face of the annular outer sleeve, whereby the distal end face of the post and the distal end face of the annular outer sleeve define a skin contacting surface having a diameter of 3.0 mm to 4.0 mm.

3. The integrated syringe according to claim 1, wherein: The distal end face of the post is spaced a distance axially inwardly from the distal end face of the annular outer sleeve, whereby the distal end face of the post and the distal end face of the annular outer sleeve define a skin contacting surface.

4. The integrated syringe according to claim 1, wherein: The sleeve has a length extending from the post of 4.0 mm to 6.0 mm, and the distal surface of the annular outer sleeve has a width of 4.0 mm to 10.0 mm.

5. The integrated syringe according to claim 1, wherein: The distal end face of the column has a radial width to contact the surface of the skin during insertion of the sleeve into the patient's skin, and the distal end face of the annular outer sleeve has an axial surface oriented relative to the column, whereby the distal end face of the column and the distal end face of the annular outer sleeve form a skin contact surface, and the skin contact surface has a structure for distributing insertion force and controlling deformation of the skin when the sleeve is inserted into the patient's body.

6. The integrated syringe according to claim 5, wherein: The distal face of the post is substantially planar and oriented in a plane substantially perpendicular to the longitudinal axis of the syringe barrel.

7. The integrated syringe according to claim 6, wherein: The distal face of the annular outer sleeve is substantially flat and has an outer edge having a convexly rounded profile, the distal face of the annular outer sleeve extending between the outer edge and an inner edge, wherein the distal face of the annular outer sleeve is substantially parallel to the distal face of the post.

8. The integrated syringe according to claim 1, wherein: The axial passage of the post has a tapered recess at the distal face of the post, and wherein adhesive is received in the tapered recess to attach the sleeve to the post, and wherein the adhesive is substantially flush with the distal face of the post to form a flat end surface.

9. The integrated syringe according to claim 1, wherein: The recess in the distal surface includes a protruding detent.

10. A syringe comprising: a syringe barrel having a medication compartment, a proximal end with a plunger, and a distal end with a seat; The seat portion has: an integral axially extending column having a distal end face and an axial channel for receiving a sleeve and communicating with the drug compartment, the sleeve having a length of 3.5 mm to 8.0 mm; and an integral axially extending annular sleeve surrounding the column and having a distal end face, the distal end face of the column and the distal end face of the annular sleeve being configured to have a size forming a skin contact surface to control deformation of the patient's skin caused by the insertion force of the sleeve and to control the penetration depth of the sleeve when the sleeve is inserted into the patient's body, wherein the column has an outer diameter of 1 mm to 2 mm, the annular sleeve has an outer diameter of 3 mm to 5 mm, the column is spaced 1 mm to 1.5 mm from the annular sleeve, and the column and the annular sleeve are spaced apart to form an annular recess, the radial width of the annular recess between the column and the annular sleeve is 0.5 mm to 3 mm, The syringe barrel further comprises at least one flange, the flange extending radially outward from the proximal end of the syringe barrel for a user to grasp, the flange having a proximal surface with at least one tactile member and / or having a distal surface with at least one tactile member, wherein the tactile member on the proximal surface of the flange is a dimple protruding outwardly from the proximal surface, and wherein the tactile member on the distal surface is a recess, wherein a substantially U-shaped open portion is formed along the outer edge of the flange, and Wherein, a protruding ridge is provided on the surface of the dimple or the recess, and the ridge extends in a curved manner on the surface of the dimple or the recess, thereby providing an additional tactile feeling.

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