Pen needle with retractable shield
By designing retractable distal and proximal needle shields on the drug delivery pen needle, and using biasing components to achieve automatic needle shielding and locking, the problems of needle exposure and reuse in the prior art are solved, improving safety and convenience of use.
Patent Information
- Application Number
- CN202010919261.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-09-06
- Filing Date
- 2020-09-04
- Publication Date
- 2026-05-15
- Estimated Expiration
- 2040-09-04
AI Technical Summary
Existing drug delivery pen needle designs are difficult to effectively cover the needle tip after use, posing a risk of accidental needle pricks, and are difficult to prevent reuse after use.
A pen needle with a retractable distal needle guard and a proximal needle guard is designed. The distal needle guard is retracted during use and extended after use to cover the distal end of the needle by a biasing member such as a spring. The proximal needle guard is locked in the extended position after use to cover the proximal end of the needle.
It effectively shields the needle after use, preventing accidental punctures and the reuse of the pen needle, thus improving safety and convenience.
Smart Images
Figure CN112451800B_ABST
Abstract
Description
Technical Field
[0001] This disclosure relates to a pen needle suitable for attachment to a drug delivery device, such as a drug delivery pen. In one embodiment, the pen needle has a needle hub with at least one retractable needle guard, wherein the needle guard can be retracted during use and extended after use to shield or cover the needle attached to the needle hub. After the pen needle has been used, the needle guard can be locked in an extended position to shield at least one end of the needle. The pen needle may include a distal needle guard for shielding the distal patient end of the needle after use, and a proximal needle guard for covering the proximal non-patient end of the needle after separation from the drug delivery device. Background Technology
[0002] Pen needles are used to attach to medication pens and are particularly useful for delivering self-administered injectable medications such as insulin. In a known commercial device, a needle holder supporting the needle is located inside a funnel-shaped outer casing, sometimes referred to as an "outer shield" or simply a "shelter." A cannula or needle is secured in an axial bore in the needle holder, with one end of the needle protruding from the distal side or "patient side" of the needle holder for injection into the patient, and the other end of the needle set into a cavity on the proximal side or "non-patient" side of the needle holder and adapted for attachment to the medication pen. A teardrop-shaped paper or foil label is heat-sealed to the edge of the open end of the funnel-shaped outer casing. Alternatively, the medication pen may have a cap received on the distal end of the medication pen where the needle is mounted. To attach the needle to the medication pen, the user removes the cap. The user then removes the label from the needle outer casing and holds the casing to attach the needle holder, typically by screwing the needle holder onto the pen. Once the needle hub is attached to the medication pen, the outer cover can be removed by pulling it distally from the needle hub. A separate inner needle shield sits on top of the needle and must be removed by the user for injection. The inner shield is typically located on the needle hub and simply helps the user position the needle without creating a sterile barrier. After use, the user can use the outer cover to unscrew the needle hub from the medication pen and dispose of the needle.
[0003] Medication pens and associated needles are disclosed in U.S. Patent No. 7,645,264 and U.S. Patent Application Publications Nos. 2009 / 0069755 and 2012 / 0022460, the entire contents of which are incorporated herein by reference. A device for arranging a releasable needle on an injection pen and releasing the needle into a mating storage or disposal container is also disclosed in U.S. Patent No. 8,057,444, which is incorporated herein by reference for its teachings.
[0004] Pen needles may include a cover or shield to cover the tip of the needle to prevent reuse and accidental punctures. Pen needles with a shield to cover the proximal end of the needle when separated from the delivery device are also known. Although existing devices are generally suitable for their intended use, there is still a need for improved pen needles in the industry. Summary of the Invention
[0005] This invention provides a pen needle for use with a drug delivery device, such as a delivery pen, to inject a drug into a patient. In one embodiment, the pen needle has a needle hub with a cannula or needle and a distal needle shield that can retract during use to expose the needle and extend after use to cover the distal end of the needle. In one embodiment, the needle shield may have a locking mechanism to lock the distal needle shield in the extended position and prevent reuse. A feature of the pen needle is: a retractable distal needle shield that can retract during use to expose the needle and slide to the extended position to cover the needle after use; and a proximal needle shield coupled to the distal needle shield when the distal needle shield is in the extended position and the proximal needle shield is in the retracted position. The pen needle includes a biasing member, such as a spring, to bias the distal and proximal needle shields to their respective extended positions.
[0006] The pen needle can be attached to a delivery pen or other delivery device, wherein the pen needle includes a proximal needle guard that can be locked in place after use to cover the non-patient end of the needle. The proximal needle guard for the non-patient end is in a retracted position before use and moves to an extended position after being separated from the delivery device to cover the non-patient proximal end of the needle in the needle hub to prevent reuse.
[0007] In one embodiment, the pen needle includes a needle hub that supports the needle or cannula. A removable cover may be attached to an end of the needle hub to cover the pen needle during storage until ready for use. A movable distal needle shield is coupled to the needle hub, which can retract during use to expose the patient end of the needle and can be deployed after use by outward movement or sliding to cover the patient end of the needle and prevent further use or accidental needlesticking. A proximal needle shield is coupled to the needle hub and moves to shield the proximal non-patient end of the needle. For example, a biasing member with a spring may be positioned between the distal and proximal needle shields to bias the needle shields outward in a distal direction.
[0008] In one embodiment, the proximal needle shield is coupled to the distal needle shield when the distal and proximal needle shields are in their initial positions before use. A coupling member connects the distal needle shield to the proximal needle shield, wherein the coupling member is detachable to separate the distal needle shield from the proximal needle shield to deploy the proximal and distal needle shields to the extended position. A biasing member is disposed within the needle holder for biasing the distal needle shield outward to the extended position covering the distal end of the needle and for biasing the proximal needle shield outward to cover the proximal end of the needle. In one embodiment, a single spring member biases the distal and proximal needle shields to their respective extended positions.
[0009] In one embodiment, the pen needle includes a needle holder with a distal needle guard that is slidable relative to the needle holder between a first extended position covering the distal end of the needle and a retracted position exposing the distal end of the needle. A proximal needle guard is disposed in the pen needle and coupled to the distal needle guard. The distal needle guard is separated from the proximal needle guard by axial movement of the distal needle guard toward the proximal end of the needle holder. In one embodiment, the distal needle guard is rotated by the axial movement to separate from the proximal needle guard, wherein a biasing member slides the proximal needle guard to an extended position and biases the distal needle guard to the extended position.
[0010] In one embodiment, a pen needle has a needle hub with a needle, the needle having a distal end extending from a distal end of the needle hub and a proximal end at a proximal end of the needle hub. A distal needle guard is movable relative to the needle hub between a first extended position to cover the needle and a retracted position to expose the needle. The distal needle guard is biased to a second extended position. When the pen needle is disengaged from the delivery device, the proximal needle guard is biased from the retracted position to the extended position to cover the proximal end of the needle. A spring having a distal end and a proximal end engages the distal needle guard to bias the distal needle guard to the extended position, and the proximal end of the spring biases the proximal needle guard to the extended position.
[0011] In one embodiment, the distal needle guard may include one or more flexible connecting tabs that engage complementary tabs on the proximal needle guard. During use, the distal needle guard rotates upon retraction, wherein the tabs separate from the tabs of the proximal needle guard, allowing a spring to bias the distal and proximal needle guards to their respective extended positions.
[0012] The pen needle includes a needle hub having a proximal end and a distal end for attachment to a delivery device. A needle is coupled to the needle hub and has a distal end extending from the distal end of the needle hub. A distal needle guard is coupled to the needle hub to slide between an extended position that covers the distal end of the needle and a retracted position that exposes the distal end of the needle. A proximal needle guard is coupled to both the needle hub and the distal needle guard. As the distal needle guard moves toward the proximal end, the distal needle guard can rotate from a first angular position to a second angular position to separate the distal needle guard from the proximal needle guard.
[0013] The pen needle features a needle hub having a needle coupled to the needle hub and having a distal end extending from a distal end of the needle hub and a proximal end for connection to a delivery device. A distal needle shield is coupled to the needle hub and is slidable between a first extended position for shielding the distal end of the needle, a retracted position for exposing the distal end of the needle to inject substance into a patient, and a second extended position for shielding the distal end of the needle. A proximal needle shield is coupled to the needle hub and is slidable from the retracted position, where the proximal end of the needle is exposed, to an extended position. In the retracted position, the proximal needle shield is coupled to the distal needle shield. The distal needle shield can be rotated from the first position to the second position by axial movement relative to the needle hub to separate the distal needle shield from the proximal needle shield.
[0014] A method is also provided for using the pen needle, for example, to inject a substance into a patient. The method involves retracting the needle shield from a first extended position to a retracted position to expose the needle and disengage it from the proximal needle shield. Then, the distal needle shield moves to a second extended position to cover the needle, thereby locking the needle shield in the extended position. The proximal needle shield moves to the extended position to cover the proximal end of the needle.
[0015] A pen needle includes: a needle hub having a distal end and a proximal end for attachment to a delivery device; and a needle coupled to the needle hub and having a distal end extending from the distal end of the needle hub. A distal needle shield is coupled to the needle hub and is slidable between a first extended position for covering the distal end of the needle, a retracted position for exposing the distal end of the needle to inject substance into a patient, and a second extended position for shielding the distal end of the needle.
[0016] In another embodiment, a pen needle includes a needle seat having: a sidewall; a proximal end for attachment to a delivery device; and a distal end. A needle is coupled to the needle seat and has a distal end extending from the distal end of the needle seat and a proximal end at the proximal end of the needle seat. A distal needle guard is coupled to the needle seat and is slidable relative to the needle seat between a first extended position for covering the distal end of the needle, a retracted position for exposing the distal end of the needle, and a second extended position for covering the distal end of the needle. The distal needle guard has a first connecting member. A proximal needle guard is contained at the proximal end of the needle seat and has a base on the distal side of an inner wall portion and a protrusion extending toward the proximal end of the needle seat through an opening in the inner wall portion of the needle seat. The proximal needle guard is movable from the retracted position where the proximal end of the needle is exposed and from the extended position relative to the proximal end of the needle. The proximal needle guard has a second connecting member configured for connection to a first connecting member of the distal needle guard. A spring has a first end and a second end, the first end of the spring contacting the distal needle guard to bias the distal needle guard to a second extended position in a distal direction, and the second end of the spring contacting the base of the proximal needle guard to bias the proximal needle guard and the protrusion to an extended position in a proximal direction.
[0017] These and other aspects and features of the pen needle will become apparent from the following detailed description and accompanying drawings of the invention. Attached Figure Description
[0018] The following is a brief description of the attached figures, in which:
[0019] Figure 1 Side view of the pen needle and pen delivery device;
[0020] Figure 2 for Figure 1 A sectional side view of the pen needle;
[0021] Figure 3 This is a partial cross-sectional perspective view of the pen needle, showing the distal needle guard and proximal needle guard in their initial position;
[0022] Figure 4 for Figure 3 A cross-sectional view of the pen needle;
[0023] Figure 5 This is a cross-sectional view of the pen needle, showing the connecting component between the distal needle guard and the proximal needle guard;
[0024] Figure 6 To show a partial cross-sectional view of the distal needle shield and the proximal needle shield;
[0025] Figure 7 This is a partial cross-sectional view showing the pen needle connected to the delivery device and the distal needle guard retracted to expose the needle;
[0026] Figure 8 A schematic diagram of the distal needle guard and the pawl on the needle hub;
[0027] Figure 9 A cross-sectional view showing the needle guard deployed in the extended and locked positions;
[0028] Figure 10 A partial perspective view of an alternative embodiment of the pen needle;
[0029] Figure 11 To show Figure 10 A three-dimensional diagram of the pen needle; and
[0030] Figure 12 for Figure 10 A three-dimensional side view of the pen needle in its deployment position.
[0031] The accompanying drawings are not drawn to scale, and some features have been omitted in certain views to better illustrate other features. Detailed Implementation
[0032] When used herein, “distal” refers to the direction toward the injection site and “proximal” refers to the opposite direction. “Axial” refers to the direction along the longitudinal axis of the device. The needle cannula is typically arranged axially within the device. “Radial” refers to the direction perpendicular to the axial direction. Therefore, “radial inward” generally means closer to the needle's axis. “Circumferential” refers to a circumferential arrangement such that the threads are circumferentially arranged at the ends of the threaded fittings. The “top” view of the pen needle is a view taken at the tip of the needle. In this document, the term “drug delivery pen” or “delivery device” refers to a device having a drug compartment typically containing multiple doses of medication and a separate pen needle. The phrase “pen needle” refers to an assembly supporting the needle, which can be attached to the body of the drug delivery pen such that the proximal end of the pen needle assembly enters the drug compartment and the distal end is adapted to be inserted into the injection site to perform one or more injections. In this document, the terms “needle” and “cannula” are used interchangeably to refer to a thin tubular member having a sharp end for insertion into an injection site on a subject. Needles or cannulas have lumens for delivering and injecting drugs into patients.
[0033] Different features of the embodiments can be combined with and used in conjunction with other embodiments, provided that the combined components do not contradict or interfere with the operation of the apparatus and components. The application of this disclosure is not limited to the construction and arrangement details of the components set forth in the following description or shown in the accompanying drawings. The embodiments herein can be modified, practiced, or performed in various ways. The wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “comprising,” “including,” or “having,” and variations thereof herein will cover the items listed thereafter and their equivalents, as well as additional items. Unless otherwise limited, the terms “connect,” “link,” and “install,” and variations thereof are used extensively herein and cover direct and indirect connections, links, and installations. Furthermore, the terms “connect” and “link,” and variations thereof, are not limited to physical or mechanical connections or links. Further, terms such as upward, downward, bottom, and top are relative and used to aid illustration, but are not limiting. The embodiments are not intended to be mutually exclusive, so features of one embodiment can be combined with other embodiments, provided they do not contradict each other. For example, degree terms such as “generally,” “approximately,” and “approximately” are understood by those skilled in the art to refer to a reasonable range around and encompassing a given value, as well as a reasonable range outside the given value, such as general tolerances associated with the manufacture, assembly, and use of an embodiment. When referring to a structure or feature, the term “generally” includes features that are present in most or all of the structure.
[0034] In one embodiment, the delivery device is a pen needle delivery device 10, such as... Figure 1 As shown, the pen needle delivery device 10 typically includes: a dosage knob / button; an outer sleeve 12; a threaded end 14 for attachment to the pen needle assembly 18; and a cap. The dosage knob / button allows the user to set the dosage of the medication to be injected. When injecting the medication, the user grasps the outer sleeve 12. The user uses the cap to securely hold the pen needle device 10 in a shirt pocket or other suitable location and to provide a cover / protection against accidental needle injuries.
[0035] In standard pen syringe devices, the dosing and delivery mechanisms reside within the outer sleeve 12, and since they are understood by those skilled in the art, they will not be described in more detail here. The cartridge is typically attached to a standard pen syringe housing via a known attachment mechanism. The plunger or stopper moves distally within the cartridge, causing the medication to be propelled into the reservoir housing. The cartridge is sealed by a diaphragm and pierced by a penetrating needle cannula located within the reservoir or housing. Although other attachment mechanisms may be used, it is preferable to screw the reservoir housing onto the cartridge. The pen syringe delivery device can be a standard pen delivery device known in the industry, and therefore is not shown in detail. Figure 2As shown, a typical pen needle assembly 18 includes: a needle seat 16 supporting the cannula 20; an outer cover 22 with ribs 23; and an inner cover 24. A protective seal 26 is attached to the open end of the outer cover, as... Figure 2 As shown, the needle hub and cannula are encapsulated to maintain a clean and sterile environment. The seal 26 can be a label or other closure that can be easily peeled off from the outer casing during use to access the needle hub.
[0036] exist Figure 3 In the illustrated embodiment, the pen needle 30 includes: a needle hub 32; a distal needle shield 70; a proximal needle shield 102; and a spring 130 for biasing the distal and proximal needle shields. The needle hub 32 has a distal end 34 for contacting the patient and a proximal end 36 for connection to the delivery pen. The needle hub 32 can be a one-piece unit or made of separate components joined together. In the illustrated embodiment, the needle hub 32 has a sidewall 38 having a generally cylindrical construction. The open proximal end 36 has a shape and construction for connection to the delivery pen 10 or other delivery device. In the illustrated embodiment, an internal thread 40 is provided at the proximal end of the sidewall for connection to a delivery device in a known manner. The pen needle 30 is configured to deliver a substance, such as insulin or other medication, to a patient. In one embodiment, the pen needle and delivery pen are configured to deliver a controlled dose of insulin to a patient.
[0037] The distal end of the sidewall 38 forming the needle holder 32 has an end wall 42 with an opening 44 forming the open distal end of the needle holder 32. The opening 44 has a size smaller than the diameter of the sidewall 38. An inner wall portion 46 is positioned within the internal cavity of the needle holder 32 defined by the sidewall 38 and extends in a plane substantially perpendicular to the longitudinal axis of the needle holder 30 and the sidewall 38. During use of the needle, the inner wall portion is fixed relative to the sidewall 38. The inner wall portion 46 extends between opposite sides of the sidewall and is connected to the sidewall by a suitable coupling mechanism. Figure 3 As shown, the inner wall portion 46 is spaced inwardly from the distal end of the sidewall and from the proximal end of the sidewall to form a cavity on each side of the inner wall portion 46. The inner wall portion defines the bottom of the distal cavity at the distal end of the sidewall and the proximal cavity at the open proximal end 36. In the illustrated embodiment, the inner wall portion 46 is received between two spaced radial ribs 48 extending radially inward from the sidewall 38 to form a groove between the ribs, the groove being sized to receive and capture the inner wall portion 46. In other embodiments, the inner wall portion may be attached by adhesive, thermal bonding, or welding. In the illustrated embodiment, the inner wall portion 46 is a separate component, but the inner wall portion 46 may be integrally formed with the sidewall or molded as a single one-piece unit.
[0038] like Figure 4 and5 As shown, the inner wall portion 46 has a central post 50 extending in a distal direction, the central post 50 having an axial channel 52 for supporting a needle 54. The post 50 extends from a distal side surface 56 of the inner wall portion 46, the distal side surface 56 being opposite to the proximal side surface 58 of the inner wall portion. The post 50 extends axially toward the distal end of the needle holder 32 and extends into a distal cavity formed by the sidewall 38. The axial channel 52 is sized to receive and support the needle 54 using an adhesive known in the art. The inner wall portion 46 includes a plurality of openings 60 spaced apart around the central post 50, wherein the openings extend through the inner wall portion between the distal side surface 56 and the proximal side surface 58. In other embodiments, the inner wall portion may have a single opening.
[0039] Needle 54 is typically a hollow needle, such as a steel needle, with a sharp tip at its distal end 62. The distal or patient end of the needle has a gauge and length for penetrating the skin to the desired depth and for delivering medication to the patient. The proximal end 64 at the proximal end of the needle hub 30 is positioned to pierce the septum in the delivery device to receive medication or drug from the delivery device in a conventional manner. The distal end 62 may have an exposed length protruding from the sidewall 38 and the distal end of the needle hub during injection, said exposed length being approximately 3-10 mm and typically approximately 4-6 mm. The needle may have a gauge range from 32 to 36. The proximal end 64 of the needle has a length to extend towards the proximal end of the needle hub to pierce the septum of the delivery pen, thereby providing a fluid connection between the delivery pen and the needle 54.
[0040] refer to Figure 3-6 The pen needle 30 includes a distal needle guard 70 and a proximal needle guard 102 for movement relative to the needle holder 32 and the needle 54. The distal needle guard 70 forms a cover or shield for the distal end 62 of the needle 54 to prevent reuse of the pen needle after use and to prevent accidental needle pricks before and after use. In the illustrated embodiment, the distal needle guard 70 is configured to slide within openings 44 in the sidewall 38 and endwall 42 of the needle holder 38. The distal needle guard... Figure 3 The extended position shown is the same as Figure 7 Slide between the retracted positions shown to expose needle 54 for injection into the patient.
[0041] In the illustrated embodiment, the distal needle shield 70 is configured to slide relative to the sidewall 38 of the needle holder 32 and the open distal end of the sidewall 38. The distal needle shield 70 has a body 74 protruding through an opening 44 in the endwall 42 of the needle holder 32. In the illustrated embodiment, the body 74 has a generally cylindrical construction. A radially extending flange 76 extends outward from the body 74 and is configured to slide within the sidewall 38. The flange 76 has a distal surface to contact the endwall 42 to restrict distal movement of the distal needle shield 70 and to capture the distal needle shield 70 within the sidewall 38 of the needle holder 32. The body 74 of the distal needle shield 70 has an axial channel 78 and an axial length to retract a certain distance to expose the distal end of the needle 54 for injection into the patient, and a length to extend to... Figure 3 The extended position shown shields and covers the distal end of needle 54. The body 74 of the distal needle shield 70 has an end wall 80 having a distal outer surface 81 forming a skin contact surface. The body 74 has a width less than the radial width of the flange 76, thereby allowing the body 74 to slide within the opening 44. The distal outer surface 81 and the end wall are shown as flat surfaces having an opening 83 to allow the needle 54 to pass through during injection. In other embodiments, the distal outer surface may have a convex shape to control the depth of needle penetration into the skin. The distal needle shield 70 is sized to shield and cover the needle in a manner that prevents the user from contacting the tip of the needle.
[0042] Flange 76 has a radial surface 82 with a rotating member shown as a pawl or protrusion 84. In the illustrated embodiment, a plurality of spaced-apart protrusions 84 are provided on the flange. In the illustrated embodiment, the protrusions 84 project radially outward from the radial surface 82. The protrusion 84 has a proximal end 86 with a curved surface having a convex shape. The curved surface forms a surface that is inclined relative to the longitudinal dimension of the distal needle guard and relative to the direction of axial movement of the distal needle guard within the needle holder 32. The protrusion 84 has a front face 88 oriented at a certain angle relative to the longitudinal axis of the needle holder 32. The inner surface 39 of the sidewall 38 of the needle holder 32 has a complementary rotating member shown as a pawl 90, which engages with the protrusions 84 of the flange 76, such as... Figure 8 As shown in the diagram, the pawl 90 protrudes inward into the axial channel of the sidewall 38 to accommodate the axial movement of the distal needle guard 70 via the protrusion 84. The pawl 90 has a complementary inclined surface 92 that is tilted relative to the axis of the needle holder 32. The pawl 90 is fixed relative to the sidewall 38 and defines a cam surface for rotating the distal needle guard 70 by axial movement of the distal needle guard 70 in the proximal direction.
[0043] When the distal needle guard 70 is positioned in its extended position to cover the needle with its flange 76 contacting the inner surface of the end wall 42, the pawl 90 is spaced a certain distance from the end wall 42, the distance corresponding to the position of the protrusion 84 on the distal needle guard 70. When the distal needle guard 70 is in its pre-use position... Figure 3 In the initial position shown, pawl 90 contacts the corresponding protrusion 84. Pawl 90 can contact protrusion 84 to hold the distal needle guard 70 in the initial extended position until ready for use. Axial movement of the distal needle guard 70 toward the proximal end of the needle holder 32 causes the distal needle guard 70 to slide across the surface of the protrusion 84 on the inclined surface of pawl 90 and rotate about the axis of the needle holder until the protrusion 84 separates from pawl 90. Then, the distal needle guard 70 can slide toward the proximal end of the needle holder to expose the distal end of the needle, as shown. Figure 7 As shown in the image.
[0044] The flange 76 of the distal needle guard 70 includes connecting members 94. In the illustrated embodiment, the flange includes two connecting members 94. In the illustrated embodiment, the connecting member 94 includes an axially extending leg 96 that extends proximally relative to the distal needle guard. A tab 98 projects from the leg and includes a distal side 100 oriented in a plane parallel to the flange 76 and perpendicular to the central axis of the distal needle guard. As shown, the tab 98 has an inclined proximal side. In one embodiment, the tab 98 projects radially outward.
[0045] The proximal needle guard 102 is positioned within the needle hub 32 to allow for the insertion of needles from the needle. Figure 3 The retraction position shown slides to Figure 9 The proximal needle guard 102 includes a base 104 oriented on the distal side of the inner wall portion 46 and spaced apart from the distal end of the sidewall 38 from the inner wall portion 46. In the illustrated embodiment, the base 104 has a generally flat construction, the generally flat construction having a rounded outer edge complementary to the cylindrical inner surface 39 of the sidewall 38. A connecting member 106 extends from the base 104 toward the distal needle guard 70 in a distal direction. In the illustrated embodiment, a pair of connecting members 106 are provided for cooperating with corresponding connecting members 94 of the distal needle guard 70. The connecting member 106 includes axially extending legs 108, each leg 108 having a connecting tab 110 at its distal end. The connecting tab 110 is formed with an undercut 111 oriented in a plane generally perpendicular to the longitudinal axis of the needle hub. Figure 5 and 6As shown, the undercut surface 111 of the connecting tab 110 engages the distal surface 100 of the tab 98 and connects the distal needle guard 70 to the proximal needle guard 102. In the illustrated embodiment, the distal surface of the connecting tab 110 has an inclined surface 116 that complements the inclined surface 118 of the tab 98 to allow the tabs 98 and 110 to slide past each other during assembly. Connecting members 94 and 106 are shown as interlocking connecting tabs. Other connecting mechanisms capable of connecting and releasing the distal and proximal needle guards can be used.
[0046] The base 104 of the proximal needle guard 102 has a central opening 120, which is sized for sliding on the post 50. In the illustrated embodiment, the base 104 has an annular collar 122 for guiding the base on the post 50, which extends about the opening 120 in a distal direction.
[0047] The base 104 has a proximal side 124 with shield members that extend through an opening 44 in the inner wall portion 46 to a protruding position to shield the proximal end of the needle 54 and limit its exposure to the patient. In the illustrated embodiment, the proximal needle shield 102 includes a plurality of shield members 126 extending axially from the base 104 in a proximal direction relative to the needle seat 32. In the illustrated embodiment, four shield members 126 are provided, but the number of shield members can be varied to provide sufficient protection against needle pricks caused by the proximal end of the needle 54. The shield members 126 are spaced apart around a central opening 120 in the base 104 to surround the proximal end of the needle 54 when moved to the deployment position to limit user contact with the needle, such as... Figure 9 As shown in the diagram. Each shield member 126 is aligned with a corresponding opening 60 formed in the inner wall portion 46 so that the shield member 126 can pass through the opening to surround the proximal end of the needle 54. The shield member 126 is deployed after the needle has been used and after the needle has been separated from the delivery pen. The proximal needle shield 102 can be locked in the deployed extended position by a locking member 156 on the sidewall, in which the shield member 126 blocks the open end of the needle hub and prevents access to the internal threads of the needle hub to prevent the needle hub from attaching to the delivery pen.
[0048] The pen needle includes a biasing member for axially biasing the distal needle guard 70 and the proximal needle guard 102 to corresponding extended positions. In the illustrated embodiment, the biasing member is a spring 130, positioned within the sidewall 38 of the needle holder 32, for axially biasing the distal needle guard 70 and the proximal needle guard 102 outward to their respective extended positions. Figure 3-6As shown in Figure 8, spring 130 has a first end 132 engaging the distal needle guard 70 and a second end 134 engaging the proximal needle guard 102. The inner surface of the end wall 42 of the distal needle guard 70 includes an annular collar 138 for stabilizing the distal end of spring 130. Spring 130 is shown as a helical spring extending between the distal needle guard 70 and the proximal needle guard 102 and surrounding the needle 54; however, other biasing members may also be used to bias the distal and proximal needle guards to an extended position. In alternative embodiments, separate biasing members may be used to bias the distal and proximal needle guards. In the illustrated embodiment, a single spring is used to simplify construction and reduce the number of components.
[0049] refer to Figure 8 The inner surface of the sidewall 38 includes a pawl 90 forming an inclined cam surface, the cam surface being inclined relative to the longitudinal axis of the sleeve. An inclined surface 92 is formed to be inclined relative to the axis of the needle seat 32 and is oriented to engage the inclined surface 86 of the protrusion 84. Figure 7 As shown, a protrusion on the distal needle guard 70 engages with the inclined surface 92, thereby causing the distal needle guard 70 to move axially inward relative to the end wall 42, causing the protrusion 84 to engage the inclined surface and allowing the distal needle guard 70 to rotate about the longitudinal axis of the needle. The distal needle guard 70 rotates relative to the proximal needle guard 102 so that the connecting tab 98 of the distal needle guard 70 separates from the connecting tab 110 of the proximal needle guard 102, thereby allowing the spring 130 to bias the proximal needle guard towards the proximal end of the needle holder 32. The guard member 126 has a proximal end positioned in a corresponding opening 60 to prevent rotational movement of the proximal needle guard 102 relative to the inner wall portion 46. In this way, the proximal needle guard 102 is non-rotatably fixed in the needle holder 32 while allowing it to slide axially from the retracted position to the extended position. The distal needle guard 70 is rotatable about the longitudinal axis of the needle 30 and the proximal needle guard 102.
[0050] like Figure 3 , 6 As shown in Figure 8, the distal needle guard 70 includes a locking member 140 for locking the distal needle guard 70 in a fixed position after use. In the illustrated embodiment, two locking members 140 are provided, each having a flexible leg 142 extending axially from the proximal end of the distal needle guard 70. The flexible leg 142 includes an outwardly extending tab 144. The tab 144 is oriented to engage with a locking member 146 on the inner surface of the sidewall 38 to retain the distal needle guard 70 in an extended position after use, such as... Figure 9As shown in the illustration. In the illustrated embodiment, the locking member 146 on the sidewall 38 is a pawl oriented to engage the tab 144. The locking member 146 is shown as a pawl projecting radially inward from the sidewall 38 to engage the tab 144 and prevent movement or retraction of the distal pin guard. Alternatively, the locking member may be a groove formed in the sidewall to capture the tab 144.
[0051] The locking member 146 is axially spaced from the distal end of the sidewall 38 such that when the distal needle guard 70 is in the extended deployment position after use, the distal needle guard will not retract to prevent the needle from being reused. The locking member 146 is oriented on the inner surface of the sidewall 38 such that the distal needle guard 70 and the proximal needle guard 102 are positioned as follows: Figure 3 When joined together in the initial position shown, the connecting tab 144 is circumferentially spaced so that the distal needle shield can retract during injection to expose the distal end of the needle. As the distal needle shield 70 rotates via the cam surfaces of the protrusion 84 and the pawl 90, the tab 144 is axially aligned with the locking member 146. The tab 144 springs radially outward to engage the locking member 146 to prevent rotation and axial movement of the distal needle shield 70 and to prevent the needle from being reused. The pawl of the locking member 146 may have spaced, longitudinally extending ribs to capture the tab 144 to prevent rotation of the distal needle shield relative to the sidewall 38.
[0052] During use, the needle hub 32 is attached to the delivery pen via a threaded connection, wherein the proximal end of the needle 54 pierces the septum of the delivery pen to provide fluid communication with the drug reservoir within the delivery pen. The distal needle shield 70 is positioned... Figure 3 In the first extended position shown, and pressed against the patient's skin, the distal needle shield 70 retracts relative to the needle and sidewall 38. Figure 7 The retracted position is shown to allow needle 54 to pierce the patient's skin.
[0053] like Figure 8 As shown, the pawl 84 of the distal needle guard 70 engages the inclined surface 92 of the pawl 90 on the inner surface of the sidewall 38, thereby causing the distal needle guard 70 to rotate relative to the proximal needle guard 102 and the sidewall 38. The axial rotation of the distal needle guard 70 causes the connecting member 94 of the distal needle guard 70 to separate from the connecting member 106 of the proximal needle guard 102, as... Figure 7 As shown in the diagram. The shield member 126 extends through a corresponding opening 60 in the inner wall portion 46 to engage with the end of the delivery pen, such that the proximal needle shield 102 remains in the retracted position until the delivery pen is separated from the needle. When the delivery pen is separated from the needle, the spring 130 biases the proximal needle shield 102 to an extended position, in which the shield member 126 extends through the opening in the inner wall portion to an extended position surrounding the proximal end of the needle, as shown in the diagram. Figure 9As shown in the diagram, the base 104 of the proximal needle guard slides over the locking member 156 on the sidewall, wherein the locking member 156 locks the proximal needle guard 102 to the... Figure 9 In the extended deployment position shown. In the illustrated embodiment, the locking member 156 on the inner surface 39 of the sidewall 38 is a pawl with an inclined distal surface 158 and a proximal locking surface 160. The inclined distal surface 158 forms a ratchet-like member that allows the base 104 to slide proximally over each member 156 and prevents the base 104 from sliding distally. By pressing against the patient's skin, the distal needle shield 70 is retracted, and the protrusion 84 and pawl 90 rotate the distal needle shield to separate the connecting members 94 and 106 and axially align the tab 144 with the locking member 146. When the needle is withdrawn from the patient, the distal needle shield slides axially to Figure 9 The second extended position shown in the diagram, in which the tab 144 slides into the corresponding locking member 146 to prevent axial and rotational movement of the distal needle guard relative to the needle hub.
[0054] Figure 10-12 An alternative embodiment of a cam mechanism for rotating the distal needle guard 70 relative to the sidewall 38 of the needle holder 32 is shown. In the illustrated embodiment, the flange 76 of the distal needle guard 70 has a radially outwardly extending protrusion 150, wherein the protrusion 150 has an inclined surface 152. The inner surface 39 of the sidewall 38 has a similar radially inwardly extending protrusion 154 for contacting the protrusion 150 of the distal needle guard 70. The protrusion 154 has a similar inclined surface 156 that engages with the inclined surface of the distal needle guard when the distal needle guard is in its initial position before use. The contacting inclined surfaces form a cam surface and rotate the distal needle guard 70 by axially moving it into the sidewall 38, and disengaging the connecting member 94 of the distal needle guard from the connecting member 106 of the proximal needle guard.
[0055] In embodiments, the components of the needle hub and sheath are typically injection-molded plastics, such as acrylonitrile butadiene styrene (ABS), polyethylene, polypropylene, or the like. The needle can be surgical-grade stainless steel. Other materials and manufacturing methods known to those skilled in the art of drug pen technology may be adapted for use herein without departing from the scope of the invention. For assembly, the needle hub assembly can be constructed separately with the needle, wherein an adhesive is applied in the interface area to secure the cannula to the needle hub, and then the sub-assembly can be assembled with other components.
[0056] The foregoing description of preferred embodiments should not be considered as a limitation of the invention, which is defined by the following claims. The foregoing description should provide sufficient information for those skilled in the art to practice variations of the described embodiments. Features and modifications described in the dependent claims or in conjunction with an embodiment may be combined with those features and modifications of another independent claim or another embodiment without departing from the scope of the invention, provided they do not contradict each other.
Claims
1. A pen needle, characterized in that, The pen needle includes: A needle hub having a distal end and a proximal end for attachment to a delivery device; A needle, which is coupled to the needle hub and has a distal end and a proximal end, the distal end of the needle extending from the distal end of the needle hub, and the proximal end of the needle extending proximally relative to the needle hub for connection to the delivery device. A distal needle shield, coupled to the needle hub, is slidable between a first extended position for shielding the distal end of the needle, a retracted position for exposing the distal end of the needle to inject a substance into a patient, and a second extended position for shielding the distal end of the needle; and A proximal needle guard, connected to the needle hub, is slidable from a retracted position to an extended position, in which the proximal end of the needle is exposed. The proximal needle guard is connected to a distal needle guard to hold the proximal needle guard in its retracted position, wherein the distal needle guard is rotatable by axial movement relative to the needle hub from a first position to a second position to separate the distal needle guard from the proximal needle guard.
2. The pen needle according to claim 1, characterized in that, The pen needle further includes a spring having a first end for biasing the distal needle guard to its extended position and a second end for biasing the proximal needle guard to its extended position.
3. The pen needle according to claim 2, characterized in that, The first end of the spring contacts the proximal end of the distal needle guard, and the second end contacts the base of the proximal needle guard.
4. The pen needle according to claim 1, characterized in that, The distal needle guard has a distal end, a proximal end, and at least one connecting member at the proximal end of the distal needle guard, the at least one connecting member being configured to connect with the proximal needle guard.
5. The pen needle according to claim 4, characterized in that, The proximal needle shield has a connecting member that is releasably connected to the connecting member of the distal needle shield when the distal needle shield is in the first extended position and the proximal needle shield is in its retracted position.
6. The pen needle according to claim 5, characterized in that, The pen needle further includes a spring extending between the distal needle guard and the proximal needle guard, and the spring is in a compressed state when the distal needle guard is engaged with the proximal needle guard.
7. The pen needle according to claim 6, characterized in that, The spring is in the extended state when the distal needle guard is in its extended position and the proximal needle guard is in its extended position.
8. The pen needle according to claim 5, characterized in that, The distal needle guard is configured to rotate relative to the needle hub by axial movement toward its retracted position, wherein the rotation of the distal needle guard causes the connecting member of the distal needle guard to disengage from the connecting member of the proximal needle guard.
9. The pen needle according to claim 8, characterized in that, The needle hub has a sidewall and an inner wall portion, the inner wall portion being oriented transversely to the axis of the needle hub and spaced between the distal end and the proximal end of the needle hub, and wherein the inner wall portion has an opening configured to receive the end of the proximal needle shield.
10. The pen needle according to claim 9, characterized in that, The proximal needle guard has a base oriented on the distal side of the inner wall portion, and a guard member oriented to extend through the opening in the inner wall portion when the proximal needle guard moves to its extended position, and the guard member has an axial length to cover the proximal end of the needle.
11. The pen needle according to claim 8, characterized in that, The inner surface of the needle hub has a rotation mechanism to rotate the distal needle shield as it moves toward the distal end of the needle hub.
12. The pen needle according to claim 10, characterized in that, The inner wall portion has a plurality of openings spaced apart around the proximal end of the needle, and the base of the proximal needle guard has a plurality of guard members extending through the corresponding openings in the inner wall portion, and the guard members have a certain axial length to cover the proximal end of the needle.
13. The pen needle according to claim 12, characterized in that, The inner wall portion of the needle hub includes a post extending toward the distal end of the needle hub, and the base of the proximal needle guard has an opening configured to slide axially on the post.
14. The pen needle according to claim 1, characterized in that, The proximal needle shield includes a plurality of connecting members extending from the distal side of the base of the proximal needle shield, and the distal needle shield includes a plurality of connecting members configured to connect with corresponding connecting members of the proximal needle shield.
15. The pen needle according to claim 14, characterized in that, The connecting member of the distal needle shield includes a connecting tab, and the connecting member of the proximal needle shield includes a connecting tab for engaging with a corresponding connecting tab of the distal needle shield to hold the proximal needle shield in the retracted position.
16. The pen needle according to claim 15, characterized in that, The distal needle guard includes a protrusion configured to engage a pawl on the needle hub when the distal needle guard is in the first extended position, and the protrusion on the distal needle guard engages the pawl on the needle hub to rotate the distal needle guard as it moves toward the proximal end of the needle hub, thereby disengaging the connecting tab of the distal needle guard from the connecting tab of the proximal needle guard.
17. The pen needle according to claim 16, characterized in that, The protrusion on the distal needle guard includes a cam surface, and the pawl on the needle seat includes a cam surface, wherein axial movement of the distal needle guard relative to the needle seat causes rotation of the distal needle guard relative to the needle seat to separate the distal needle guard from the proximal needle guard.
18. The pen needle according to claim 17, characterized in that, The protrusion on the distal needle guard protrudes radially outward relative to the axis of the distal needle guard, and the pawl on the needle seat protrudes radially inward.
19. The pen needle according to claim 18, characterized in that, The distal needle guard includes a locking member to lock the distal needle guard in a second extended position, and the sidewall includes a locking member to lock the proximal needle guard in its extended position.
20. The pen needle according to claim 1, characterized in that, The needle hub has a sidewall and an inner wall portion with an opening extending laterally relative to the sidewall, and the proximal needle shield extends through the opening in the inner wall portion. The proximal needle shield has a distal end on a first side of the inner wall portion for engaging a biasing member, and a proximal end on a second side of the inner wall portion for shielding the proximal end of the needle.
21. A pen needle, characterized in that, The pen needle includes: A needle hub having: a sidewall; an inner wall portion extending laterally relative to the sidewall; a proximal end for attachment to a delivery device; and a distal end; A needle, which is connected to the needle hub and has a distal end and a proximal end, the distal end of the needle extending from the distal end of the needle hub and the proximal end of the needle at the proximal end of the needle hub. A distal needle guard, the distal needle guard being coupled to the needle hub and for sliding relative to the needle hub between a first extended position for shielding the distal end of the needle, a retracted position for exposing the distal end of the needle, and a second extended position for shielding the distal end of the needle, the distal needle guard having a first connecting member. A proximal needle guard at the proximal end of the needle hub, the proximal needle guard having: a base on the distal side of an inner wall portion; and a guard member extending toward the proximal end of the needle hub through an opening in the inner wall portion of the needle hub, the proximal needle guard being movable from a retracted position where the proximal end of the needle is exposed and an extended position relative to the proximal end of the needle, the proximal needle guard having a second connecting member configured to connect to the first connecting member of the distal needle guard and hold the proximal needle guard in its retracted position; and A spring having a first end and a second end, the first end of the spring contacting the distal needle guard to bias the distal needle guard to a second extended position in a distal direction, and the second end of the spring contacting the base of the proximal needle guard to bias the proximal needle guard and the guard member to an extended position.
22. The pen needle according to claim 21, characterized in that, When the distal needle guard is connected to the proximal needle guard, the spring is in a compressed state.
23. The pen needle according to claim 21, characterized in that, The distal needle guard is configured to rotate relative to the needle hub by axial movement of the distal needle guard toward the proximal end of the needle hub, thereby separating the first connecting member from the second connecting member.
24. The pen needle according to claim 23, characterized in that, The distal needle guard has a protrusion and the sidewall of the needle hub has a pawl, the pawl being configured to engage the protrusion on the distal needle guard to hold the distal needle guard in the first extended position and to rotate the distal needle guard by axial movement of the distal needle guard.
25. The pen needle according to claim 24, characterized in that, The first connecting member includes a first connecting tab and the second connecting member includes a second connecting tab configured for removably connecting to the first connecting tab.
26. The pen needle according to claim 25, characterized in that, The proximal needle guard has a plurality of guard members extending from the proximal side of the base, the guard members being configured to extend through an opening in the inner wall portion when the proximal needle guard is in its extended position, and the guard members surrounding the tip of the proximal end of the needle.