Source: https://patents.google.com/patent/JP5938402B2/en
Timestamp: 2019-11-17 21:37:16
Document Index: 651428621

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'arts 1', 'art 1', 'art 1', 'art 1', 'art 1', 'arts 1', 'art 1', 'art 1']

JP5938402B2 - Safety devices for drug-filled syringes and injection devices - Google Patents
Safety devices for drug-filled syringes and injection devices Download PDF
JP5938402B2
JP5938402B2 JP2013517172A JP2013517172A JP5938402B2 JP 5938402 B2 JP5938402 B2 JP 5938402B2 JP 2013517172 A JP2013517172 A JP 2013517172A JP 2013517172 A JP2013517172 A JP 2013517172A JP 5938402 B2 JP5938402 B2 JP 5938402B2
JP2013517172A
JP2013529988A (en
2013-07-25 Publication of JP2013529988A publication Critical patent/JP2013529988A/en
2015-12-04 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43297166&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP5938402(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
2016-06-22 Publication of JP5938402B2 publication Critical patent/JP5938402B2/en
The present invention relates to a safety device that provides needle safety, and in particular to a safety device for a prefilled syringe. The safety device is adapted to avoid needle stick accidents and needle damage due to negligence before, during, and after injection of a drug or drug contained in a pre-filled syringe. In particular, the safety device provides needle safety for subcutaneous self-administration injections or injections administered by healthcare professionals. The invention further relates to an injection device consisting of a prefilled syringe.
A drug-filled syringe filled with a selected drug dose is a well-known injection device for administering a drug to a patient. Safety devices for covering the needles of prefilled syringes before and after use are also well known. Typically, these devices comprise a needle shield that is manually moved to surround the needle or actuated by a relaxation spring.
Different types of safety devices known in the state of the art provide needle safety by placing a prefilled syringe movable relative to the body and allowing the prefilled syringe to be withdrawn from the body after injection. It solves the problem of providing.
One object of the present invention is to provide an improved safety device for a prefilled syringe.
It is a further object of the present invention to provide an improved injection device comprising a pre-filled syringe that is safe to handle and in particular prevents accidental needle stick accidents.
This object is achieved by a safety device according to claim 1 and an injection device according to claim 17.
According to the present invention, a safety device for a prefilled syringe comprises a hollow support holding the prefilled syringe therein, a hollow needle shield that is slidable relative to the support, Guiding means for guiding the movement of the needle shield relative to the support. The guide means comprises a flexible arm, a guide track and a separation wall. A guide pin extends radially from the flexible arm and protrudes from the guide track. The separating wall extends into the guide track in a direction parallel to the central axis of the safety device. When the needle shield slides relative to the support, the guide pin moves along the guide track, deflects the flexible arm in a transverse direction perpendicular to the central axis, and the guide pin The movement of the guide pin along the track is guided by the interaction of the flexible arm and the separating wall.
When the needle shield is slid relative to the support to cover and / or expose the hypodermic needle of a drug-filled syringe, particularly inserted in the support of the safety device The pin is moved along the guide track. The movement of the needle shield is controlled by guide pins that move between various positions within the guide track. The interaction of the deflectable flexible arm with the separation wall allows the guide pins to be guided along the guide track and prevents relative rotation of any external parts such as the needle shield and support. . The friction between these rotating external parts and the patient's skin is uncomfortable, especially when the external parts of the safety device come into contact with the patient's skin during an injection, especially while the hypodermic needle still penetrates the skin. It can even give pain to the patient. Therefore, this safety device can perform safe and convenient injection of drugs.
The flexible arm is connected to either the needle shield or the support. The guide track is formed on the other of the needle shield or the support. Accordingly, it is within the scope of the present invention for the safety device to comprise a support with a guide track and a needle shield with a flexible arm, or the flexible arm can be attached to the support. It is within the scope of the present invention that the connected and guide tracks are formed on the needle shield.
The separating wall extends into the widened section of the guide track that extends parallel to the central axis of the safety device. The separation wall, together with the flexible arm, guides the movement of the guide pin within the guide track, prevents the guide pin from re-entering the start position, and is efficient for guiding toward the end position. Provide mechanism. The guide pin in the end position permanently holds the needle shield in the advanced position, where the needle shield protrudes from the support and holds the hypodermic needle of the drug-filled syringe held in the support. Surrounding. The separation wall prevents re-exposure of the hypodermic needle after a single use of the safety device, and in particular prevents accidental needle sticks with contaminated needles.
As soon as the guide pin passes the separating wall, the safety device is prevented from being reused. The separation wall has an axial dimension that extends parallel to the central axis, which is supported by the needle shield until the guide pin can pass through the flexible wall to prevent reuse of the safety device. It substantially defines the shortest axial distance that must be moved proximally relative to the body. If the needle shield is accidentally pushed proximally by an axial length that is smaller than the axial dimension of the flexible wall, the safety features that prevent reuse are not activated. Thus, accidental activation of safety features that prevent reuse of the safety device is avoided.
According to a possible embodiment of the present invention, audible feedback is generated when the needle shield is retracted relative to the support by a distance that matches or exceeds the shortest axial distance. It is done. This indicates that the user of the safety device can activate a safety feature that prevents accidental needle sticks after a single injection and prevents reuse.
The separating wall prevents the guide pin from accessing the end position from either the distal or proximal direction, so that the guide pin is in the other direction of the distal or proximal direction The end position can be entered from. The separation wall provides the necessary means for retracting the needle shield to expose the hypodermic needle before the guide pin is accessible to the end position.
According to another embodiment, the separation wall is either fixed or flexible and deflectable.
According to a possible embodiment of the invention, the guide track is formed as a recess either on the surface of the support or on the surface of the needle shield. The guide track does not pass completely through the wall of the corresponding part in which it is formed. According to a possible embodiment, this corresponding part may be a needle shield or a support. This ensures that there is no direct access from outside to inside of the safety device, thus making the safety device more robust. In addition, the structural stability of the portion having the guide track is improved. Since the support and needle shield are preferably formed by an injection molding process, a guide track molded as a depression additionally eliminates molding defects known as flash along the guide track. . A flush occurs when excess material exceeds the normal partial geometry. Therefore, if the guide track has a concave shape, flushing is avoided and the smoothness of the guide track is improved.
According to another embodiment, the guide track forms an opening in either the support or the needle shield. As a result, the separation wall is deflected in the lateral direction and can be offset.
According to the same embodiment of the invention, the deflection of the flexible separating wall depends on the deflection of the flexible arm supporting the guide pin. The dependent interaction of the flexible arm and the flexible separating wall reduces the required degree of deflection from the flexible arm and safely guides the guide pin along the guide track. In addition, this dependent interaction reduces the amount of time that the flexible arm needs to be in its maximum load. Thus, the force applied by the user to the safety device to move the needle shield relative to the support is reduced.
According to the same embodiment, the elasticity of the flexible separating wall is adapted to the elasticity of the flexible arm, and the flexible separating wall can be deflected by the biased and loaded flexible arm. is there. The amount of work done by the user to bias the flexible arm is substantially transferred to the flexible separation wall to bias the flexible wall. Advantageously, the flexible separating wall and the flexible arm are manufactured from the same resilient plastic material or from different plastic materials having approximately the same elasticity.
The guide pin is biased laterally by a biased flexible arm. According to one embodiment of the invention, the biased guide pin applies a force laterally against the flexible separation wall, which biases the separation wall and activates the safety features of the safety device. According to another embodiment of the invention, the guide pin is biased by a flexible arm and passes laterally through the separation wall.
In the rest position, the flexible arm extends substantially parallel to the central axis. The safety device is stored with its flexible arm in its rest position and loaded during the first single use of the safety device. Since the flexible arm is typically a biasing means made from a resilient plastic material that is prone to material fatigue, avoid storing the flexible arm under load, It is advantageous to extend the shelf life.
The guide track comprises an inclined section oriented at an acute angle with respect to the central axis. As the guide pin moves along the inclined section of the guide track, the flexible arm is biased and loaded. Thus, this design of the guide track allows the flexible arm to be loaded during use of the safety device and avoids material fatigue. Thus, needle safety is reliably provided even after storage.
The needle shield is held in the initial position by a guide pin held in the inclined section of the guide track in the starting position. The needle shield in the initial position protrudes distally from the support.
According to one possible embodiment, the needle shield is made from an opaque plastic material. A hypodermic needle is hidden from the patient's eye prior to injection by a needle shield held in the initial position. This relieves potential patient anxiety about the needle. Thus, the safety device is particularly suitable for performing self-administration injections.
According to another embodiment, the needle shield is made from a transparent plastic material. This allows health care professionals using safety devices to visually identify the correct location of the hypodermic needle piercing the patient's skin, even when the hypodermic needle is surrounded by a needle shield. .
When the needle shield is in the initial position, the compression spring is placed in an unloaded state. Since the safety device is stored and transported with the needle shield held in the initial position, material fatigue of the compression spring is avoided. Thus, the shelf life of the safety device is extended. Furthermore, since the requirements for the material of the compression spring are low, safety devices can be mass-produced cost-effectively.
The needle shield is movable from an initial position to a retracted position and further to an advanced position. The needle shield protrudes from the support in the advanced position. In the retracted position, the needle shield is substantially contained within the support.
Alternatively, the generally cylindrical needle shield comprises a radial diameter dimensioned to receive the support in a substantially retracted position. In this alternative embodiment, the support slides into the needle shield when the needle shield is moved from the advanced position to the retracted position.
In the advanced position, the needle shield extends distally from the support. The movement of the guide pin within and along the guide track controls the protrusion and retraction of the needle shield to allow safe injection.
The injection device comprises a drug-filled syringe that is held within the support of the safety device. The prefilled syringe includes a hypodermic needle attached to its distal end, a barrel with an internal cavity in fluid communication with the hypodermic needle, and a piston that fluidly seals the proximal end of the inner cavity. It becomes. The piston can be moved by actuating a piston rod protruding from the proximal end of the barrel. Since the prefilled syringe is held in the support body of the safety device, the hypodermic needle protrudes from the distal end of the support body. The hypodermic needle of the injection device is surrounded by the needle shield in the advanced position in the initial position, and the hypodermic needle is exposed when the needle shield is in the retracted position. An injection device comprising a pre-filled syringe and a safety device combines the above advantages, avoiding accidental needle sticks before, during and after injection to deliver the drug under the patient's skin it can.
Details of the present invention will be described below. However, it should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are provided for purposes of illustration only. Various changes and modifications to the illustrated embodiments within the spirit and scope of the present invention will be apparent to those skilled in the art.
FIG. 2 shows a perspective view of an injection device according to a first embodiment of the invention comprising a safety device and a pre-filled syringe before use. FIG. 3 shows a cross-sectional view of an injection device according to a first embodiment of the invention with a safety device comprising a needle shield held in an initial position. FIG. 3 shows a cross-sectional view of an injection device according to a first embodiment of the invention, shown with a safety device with a needle shield held in a retracted position. FIG. 6 shows a perspective view of a safety device support and needle shield with the needle shield held in the retracted position. FIG. 2 shows a cross-sectional view of the injection device according to the first embodiment of the present invention after injection has been performed. A to F show details of the guide track and the movement of the guide pin in the guide track during use of the safety device according to the first embodiment of the invention. Fig. 4 shows a perspective view before use of an injection device according to a second embodiment of the invention comprising a safety device and a prefilled syringe. For convenience of explanation, a perspective view of the support according to the second embodiment shown cut open with respect to the central axis is shown. A to E show details of the guide track and the movement of the guide pin in the guide track when the safety device according to the second embodiment of the invention is used.
FIG. 1 shows an injection device D having a safety device 1 for a drug-filled syringe 2 according to a first embodiment of the invention, which is to be provided to a user performing the injection. The safety device 1 comprises a substantially cylindrical and hollow needle shield 1.1. The needle shield 1.1 is housed in a substantially cylindrical and hollow support 1.2 and is slidable relative to the support 1.2. Prior to use of the safety device 1, the needle shield 1.1 is held in the initial position I and protrudes from the support 1.2.
Alternatively, the generally cylindrical needle shield 1.1 comprises a radial diameter dimensioned to substantially accommodate the support 1.2. In this alternative embodiment, the support body 1.2 slides into the needle shield 1.1 when the needle shield 1.1 is moved from the initial position I to the retracted position II.
FIG. 1 shows a safety device 1 comprising a generally cylindrical, hollow outer body 1.3 having an open distal end and a closed proximal end. The proximal end of the support body 1.2 is housed within the open distal end of the outer body 1.3, where the outer body 1.3 is substantially within the outer body 1.3. It is slidable distally with respect to the support 1.2 so as to receive the support 1.2.
A hand flange 1.3.1 projecting outward in the circumferential direction is integrally formed on the outer surface of the outer body 1.3 close to the distal end.
Preferably, the needle shield 1.1, the support body 1.2 and the outer body 1.3 are made from a plastic material.
The needle shield 1.1 comprises a circumferential skin contact surface 1.1.1 at its distal end. The skin contact surface 1.1.1 is adapted to be pressed against the patient's skin and projects radially outwards at right angles to the central axis A of the safety device 1. The edges of the skin contact surface 1.1.1 that will come into contact with the patient's skin are rounded to prevent injury. The skin contact surface 1.1.1 has a central opening located on the central axis A of the safety device 1. The skin contact surface 1.1.1 is an integral part of the needle shield 1.1 or a separate part made of plastic material attached to the needle shield 1.1.
A first longitudinal tongue 1.1.2 opposite the two diameters is formed on the outer surface on both sides of the needle shield 1.1. Each first longitudinal tongue 1.1.2 projects radially outward and extends over a certain axial length parallel to the central axis A of the needle shield 1.1. As best seen in FIG. 2, the first longitudinal tongue 1.1.2 is received in a corresponding first longitudinal groove 1.2.1 formed in the inner surface of the support body 1.2. Relative rotation of the support 1.2, needle shield 1.1 is prevented by the first longitudinal groove 1.2.1 receiving the first longitudinal tongue 1.1.2 of the needle shield 1.1. Is done.
Similarly, the support body 1.2 includes at least one second longitudinal tongue 1.2.2 that is received in a second longitudinal groove (not shown) formed in the inner surface of the outer body 1.3. Thereby, the relative rotation of the outer body 1.3 and the support body 1.2 is prevented.
Two longitudinal recesses 1.3.2 are formed on both sides of the outer body 1.3 and extend parallel to the central axis A over a certain axial length of the outer body 1.3. ing. The longitudinal recess 1.3.2 includes two parts, a first part 1.3.2.1 and a second part 1.3.2.2 separated from each other by a web 1.3.3. It becomes.
Each longitudinal recess 1.3.2 receives a corresponding outward projection 1.2.3 that is an integral part of the support body 1.2. When the outer body 1.3 is slid relative to the support 1.2, the outward projection 1.2.3 moves into the longitudinal recess 1.3.2 to carry out the injection stroke; At this time, relative rotation of the outer body 1.3 with respect to the support body 1.2 is prevented.
Prior to injection, the outward projection 1.2.3 is held in the first part 1.3.2.1 of the longitudinal recess 1.3.2. The outward projection 1.2.3 can be deflected radially inward and when the outer body 1.3 is pushed distally with respect to the support 1.2, the outward projection 1.. 2.3 leaves the first part 1.3.2.1 and enters the second part 1.3.2.2. The shape and elasticity of the outward projection 1.2.3 and the first part 1.3.2.1 of the longitudinal recess 1.3.2 are such that the outward projection 1.2.3 is the first part 1.2.1. The force required to leave 3.2.1 is adjusted to exceed the force required to move the needle shield 1.1 from the initial position I to the retracted position II. This ensures a gradual movement of the needle shield 1.1, support 1.2 and outer body 1.3 during injection, as will be explained in more detail below.
The longitudinal recess 1.3.2 shown in FIG. 1 has the shape of a slot. Alternatively, the longitudinal recess 1.3.2 is formed on the inner surface of the outer body 1.3 so that the outward projection 1.2.3 extends in the outer recess 1.3. Move along 2 and make it inaccessible from the outside.
A clamp arm 1.3.4 is formed in the substantially cylindrical outer body 1.3 and can be deflected in a radial direction perpendicular to the central axis A. As best seen in FIG. 5, the clamping arm 1.3.2 is located in a locking recess 1.2.2 formed in the support 1.2 close to the distal end of the support 1.2. Inwardly projecting locking catch 1.3.2.1.
The guide pin 1.1.3 is formed integrally with the flexible arm 1.1.4 of the needle shield 1.1. The flexible arm 1.1.4 extends substantially parallel to the central axis A of the safety device 1 in its rest position. As shown in FIG. 1, the guide pin 1.1.3 extends radially outward into a guide track 1.2.2 formed as a hole in a substantially cylindrical support 1.2. A trapezoidal cut-out 1.1.5 is formed in the needle shield 1.1 adjacent to the flexible arm 1.1.4 so that the deflection and rotation of the flexible arm 1.1.4 is achieved. Enables dynamic movement. Prior to use of the safety device 1, the guide pin 1.1.3 is at the starting position PI at the distal end of the guide track 1.2.5 and the inclined section 1. Held in 2.5.1. When the flexible arm 1.1.4 is in the rest position, the guide pin 1.1.3 is not biased laterally in the starting position PI. The inclined section 1.2.5.1 is oriented at an acute angle with respect to the cylindrical axis A of the safety device 1.
The needle shield 1.1 is brought into the initial position I by a guide pin 1.1.3 held in the inclined section 1.2.5.1 of the guide track 1.2.5 in the starting position PI. Retained. The needle shield 1.1 is made of an opaque plastic material and the hypodermic needle 2.1 is hidden from the patient's eye through the injection.
Alternatively, the needle shield 1.1 is made from a clear plastic material so that the health care professional performing the injection can visually identify the correct position of the hypodermic needle 2.1 before penetrating the patient's skin. I can confirm.
The guide pin 1.1.3 is prevented from leaving the starting position PI by the interaction of several components of the safety device 1. The flexible arm 1.1.4 biases the guide pin 1.1.3 in the lateral direction L, the guide pin 1.1.3 is inclined in the lateral direction L and in the distal direction. 2. Abutting the distal end of 2.5.1 and, as best seen in FIG. 2, a compression spring 1.4 is located between the support 1.2 and the needle shield 1.1, The shield 1.1 and the guide pin 1.1.3 connected thereto are biased in the distal direction.
The guide track 1.2.5 comprises a widening section 1.2.5.2 extending parallel to the central axis A of the safety device 1. A separating wall 1.2.6 extends parallel to the central axis A and projects into the widened section 1.2.5.2 from the distal direction. The separating wall 1.2.6 is integral with the support body 1.2 and prevents the guide pin 1.1.3 from returning to the starting position PI after the injection stroke has been performed. Furthermore, the separating wall 1.2.6 guides the movement of the guide pin 1.1.3 in the guide track 1.2.5, the guide pin 1.1.3 being in the distal direction Is prevented from entering the end position PIII, but is allowed to enter from the proximal direction. The end position PIII is defined by a generally U-shaped notch between the distal and proximal ends of the guide track 1.2.5.
According to the first embodiment of the invention shown in FIGS. 1-6F, the separating wall 1.2.6 is flexible and can be deflected in the lateral direction L.
The injection device D comprises a safety device 1 having a drug-filled syringe 2 held in a support 1.2. FIG. 2 shows a medicament housed in a support 1.2 comprising a hypodermic needle 2.1 covered by a needle cap 2.2 frictionally attached to the distal end of the barrel 2.3. The filled syringe 2 is shown. Barrel 2.3 has an internal cavity 2.3.1 that contains the drug. The internal cavity 2.3.1 is in fluid communication with the hypodermic needle 2.1. The proximal end of the inner cavity 2.3.1 is fluid tightly sealed by a piston 2.4 which is connected to a piston rod 2.5. The piston 2.4 is movable in the proximal direction at least in the distal direction by actuating a piston rod 2.5 protruding from the barrel 2.3. The barrel 2.3 of the prefilled syringe 2 is a barrel collar 2.3 which abuts the radially inwardly projecting inner surface of the support 1.2 at the proximal end where it is attached to the support 1.2. .2.
As can be seen by cross-referencing FIG. 4, the support 1.2 is a clip 1.2.7 that engages the barrel collar 2.3.2 to hold the drug-filled syringe 2 therein. Comprising.
The medicine-filled syringe 2 is held in the support body 1.2, and the hypodermic needle 2.1 protrudes from the support body 1.2 in the distal direction.
1 and 2, the hypodermic needle 2.1 is covered by a needle cap 2.2 surrounded by a needle shield 1.1 before use of the injection device D. Yes. Needle cap 2.2 is preferably made, at least in part, from a plastic material such as rubber. The width of the central opening of the skin contact surface 1.1.1 corresponds to the outer diameter of the needle cap 2.2. The needle cap remover 3 is inserted into the central opening of the skin contact surface 1.1.1 and protrudes from the skin contact surface 1.1.1 in the distal direction, so that the user can By pulling the needle cap remover 3, the needle cap 2.2 can be easily removed from the medicine-filled syringe 2. The needle cap remover 3 comprises clamping means 3.1 that secure it to the distal end of the needle cap 2.2.
Alternatively, an injection device D comprising a safety device 1 and a drug-filled syringe 2 held therein has a needle attached to the distal end of a needle cap 2.2 held in the safety device 1. The cap remover 3 is shipped to the end user together with the cap remover 3 and delivered. At this time, the needle cap remover 3 protrudes from the needle shield 1.1 in the distal direction.
The proximal end of the piston rod 2.5 abuts the closed distal end of the outer body 1.3 so that the piston 2.4 is in the distal direction of the outer body 1.3 relative to the support 1.2. It can be moved in the distal direction by displacement.
Alternatively, the piston rod 2.5 is connected to the outer body 1.3 or is an integral part of the outer body 1.3. This alternative embodiment has the additional advantage that the overall number of parts is reduced and manufacturing costs are reduced.
The needle shield 1.1 is in a first position I that surrounds the hypodermic needle 2.1 of the drug-filled syringe 2. The compression spring 1.4 is placed in the safety device 1 in a partially loaded state and pushes the inner surface of the needle shield 1.1 in the distal direction and closes the inner surface of the support 1.2. Pushing in the lateral direction, thereby urging these two parts 1.1.1.2 away from each other. The needle shield 1.1 is held in the initial position I by a guide pin 1.1.3 which is in contact with the support body 1.2 at the starting position PI.
FIG. 3 shows a cross-sectional view of the needle shield 1.1 in the retracted position II, where the needle shield 1.1 is substantially contained within the support 1.2. The hypodermic needle 2.1 projects distally from the skin contact surface 1.1.1 of the needle shield 1.1. The compression spring 1.4 arranged in the safety device 1 is fully compressed and fully loaded.
FIG. 4 shows a perspective view of the needle shield 1.1 in the retracted position II, where the needle shield 1.1 is substantially housed within the support 1.2. The guide pin 1.1.3, which is an integral part of the needle shield 1.1, is in an intermediate position PI in the guide track 1.2.5 near its proximal end. The intermediate position PI corresponds to the retracted position II of the needle shield 1.1.
The support body 1.2 further comprises two clips 1.2.7 arranged diametrically opposite each other. The clip 1.2.7 is located near the proximal end of the support 1.2 and clamps the collar 2.4 of the drug-filled syringe 2 to attach the drug-filled syringe 2 to the support 1.2. Hold the syringe 2 filled with the drug firmly in the support 1.2.
FIG. 5 shows a cross-sectional view of the injection device D according to the first embodiment of the present invention after injection of a medicine. The cross-sectional view shown in FIG. 5 has been rotated with respect to the cross-sectional views shown in FIGS. Needle shield 1.1 protrudes distally from support 1.2 in advance position III, and hypodermic needle 2.1 is surrounded by needle shield 1.1 and is accidental Prevents needle stick accidents. The needle shield 1.1 is fixed in the advance position III by a guide pin 1.1.3 held in the end position PIII.
The piston 2.4 is fully pushed into the barrel 2.3 of the prefilled syringe 2. The support body 1.2 is accommodated in the outer body 1.3 and locked against it, so that reuse of the safety device 1 is prevented. An inward protruding locking catch 1.3.4.1 formed on the clamp arm 1.3.4 irreversibly locks the support 1.2 against the outer body 1.3 It latches in the corresponding locking recessed part 1.2.4 formed in the support body 1.2.
6A-6F show details of the guide track 1.2.5 formed on the support 1.2 and in the guide track 1.2.5 during use of the safety device 1 according to the first embodiment. The movement of the guide pin 1.1.3 is shown. 6A-6F show the dependent interaction of the flexible arm 1.1.4 with the flexible and deflectable separating wall 1.2.6.
As shown in FIG. 6A, the guide pin 1.1.3 is held in the starting position PI at the distal end of the inclined section 1.2.5.1 of the guide track 1.2.5 before injection. The needle shield 1.1 is fixed at the initial position I. In the initial position I, the hypodermic needle 2.1 is surrounded by a needle shield 1.1.
The injection is performed by directing the central axis A approximately perpendicular to the patient's skin. At this time, the skin contact surface 1.1.1 of the needle shield 1.1 rests on the skin surface of the patient and is proximal to the outer body 1.3 on the proximal side of the hand flange 1.3.1. The part is gripped by the user performing the injection. The hand flange 1.3.1 supports the user's hand to perform the injection stroke, whereby the outer body 1.3 is moved toward the patient's skin surface to initiate the injection.
Injection is performed in multiple stages. In the first stage, the needle shield 1.1 is pushed proximally into the support body 1.2 against the biasing force of the spring means 1.4. As shown in FIG. 6B, the guide pin 1.1.3 leaves its starting position PI and moves along the inclined section 1.2.5.1 of the guide track 1.2.5. With the distal end portion 1.2.5.1 oriented at an acute angle with respect to the central axis A, movement of the guide pin 1.1.3 causes the flexible arm 1.1.4 to move laterally. A bias is applied and thereby the guide pin 1.1.3 is biased laterally.
The guide pin 1.1.3 further moves in the proximal direction along the guide track 1.2.5. As shown in FIG. 6C, the guide pin 1.1.3 enters the widened section 1.2.5.2 of the guide track 1.2.5 and in the lateral direction the flexible separating wall 1.2. .6 abuts. The force applied by the loaded flexible arm 1.1.4 causes the flexible separating wall 1.2.6 to be laterally offset. The elasticity of the flexible separating wall 1.2.6 is matched to match the elasticity of the flexible arm 1.1.4, so that the flexible separating wall 1.2.6 is offset. It can be deflected by a flexible arm 1.1.4 which is loaded.
The separating wall 1.2.6 allows the guide pin 1.1.3 to enter the end position PIII since the guide pin 1.1.3 enters the widened section 1.2.5.2 from the distal direction. To prevent.
The guide pin 1.1.3 further moves in the proximal direction towards the intermediate position PII and reaches the proximal end of the flexible separating wall 1.2.6, as shown in FIG. 6D. At this point, the flexible separating wall 1.2.6 relaxes and rebounds to its rest position substantially parallel to the central axis A, so that the safety features of the safety device 1 are activated. From here, the end position PIII is accessible and the guide pin 1.1.3 can enter this position and is prevented from re-entering the start position PI. When the safety device 1 is removed, the needle shield 1.1 and the guide pin 1.1.3 are advanced in the distal direction, and the needle shield 1.1 is in the advanced position III. Surround 2.1.
The separating wall 1.2.6 extends parallel to the central axis A and has an axial dimension extending into the widened section 1.2.5.2 of the guide track 1.2.5. This axial dimension is safe because the needle shield 1.1 has to move relative to the support 1.2 before the position III is accessible and the needle shield 1.1 reaches it. Define the shortest axial distance that activates a safety feature that prevents reuse of the device 1. This prevents unintentional activation of the safety features of the safety device 1 when the needle shield 1.1 is accidentally pushed distally by an axial length that is shorter than the shortest axial distance.
The safety device 1 generates audible feedback indicating activation of the safety feature. The audible feedback indicates that the flexible separating wall 1.2.6 is moved when the needle shield 1.1 is moved distally relative to the support 1.2 by an axial length that exceeds the shortest axial distance. It can be generated by rebounding to its rest position substantially parallel to the central axis A.
Before the drug is released through the hypodermic needle 2.1, the needle shield 1.1 is further moved in the proximal direction until it reaches the retracted position III shown in FIG. The pin 1.1.3 is held in the intermediate position PII by the guide track 1.2.5. Here, the compression spring 1.4 is sufficiently compressed and fully loaded. In the second subsequent stage of the injection, the hypodermic needle 2.1 can penetrate the patient's skin and the drug contained in the internal cavity 2.3.1 can be injected.
Through the first stage of the injection, the outward projection 1.2.3 is held in the first part 1.3.2.1 of the longitudinal recess 1.3.2 and is relative to the support 1.2. Distal movement of the outer body 1.3 is prevented. When the guide pin 1.1.3 reaches the intermediate position PII and the needle shield 1.1 enters the corresponding retracted position II, the outward projection 1.2.3 is biased radially inward, Leave the first part 1.3.2.1 and enter the second part 1.3.2.2 of the longitudinal recess 1.3.2. As a result, the outer body 1.3 can move relative to the support 1.2 in the second stage of injection.
In the second stage, the outer body 1.3 moves in the distal direction relative to the support body 1.1. At the same time, the piston rod 2.5 interacting with the outer body 1.3 is actuated to move the piston 2.4 in the distal direction and the drug contained in the internal cavity 2.3.1 is injected subcutaneously. It is delivered through the needle 2.1 and under the patient's skin.
At the end of the injection stroke, an inwardly projecting locking catch 1.3.4.1 formed on the clamp arm 1.3.4 has a corresponding locking recess 1 formed on the support 1.2. 2. Hang on 2.4 and irreversibly lock support 1.2 against outer body 1.3.
The injection device D comprising the safety device 1 and the drug-filled syringe 2 housed therein is removed from the skin surface. Immediately, the needle shield 1.1 is moved in the distal direction towards the advanced position PIII by the action of the relaxing compression spring 1.4. As shown in FIG. 6E, the guide pin 1.1.3 moves distally with the needle shield 1.1 and is guided towards the end position PIII by the separating wall 1.2.6.
As shown in FIG. 6F, the guide pin 1.1.3 enters a U-shaped notch that defines the end position PIII of the guide track 1.2.5, so that the flexible arm 1.1.4 Relax and move the guide pin 1.1.3 laterally towards the end position PIII.
The guide pin 1.1.3 is held firmly in the end position PIII because it abuts the U-shaped notch in the distal and lateral directions. At this time, the flexible arm 1.1.4 is in a stationary position where the guide pin 1.1.3 is not biased laterally at the end position PIII. Lateral movement of the guide pin 1.1.3 is prevented by the U-shaped notch shape of the guide track 1.2.5 and the flexible arm 1.1.4 at the end position PIII. Thus, after a single use of the safety device 1, the guide pin 1.1.3 in the end position PIII irreversibly locks the needle shield 1.1 in the advanced position III.
In one embodiment of the invention, hypodermic needle 2.1 is hidden from the patient's eye through injection.
FIG. 7 shows a perspective view of an injection device D according to a second embodiment of the invention. The safety device 1 of the injection device D comprises a hollow support 1.2 and two substantially flat sides 1.2.8 arranged opposite each other. One guide track 1.2.5 is formed on the outer surface of each of the two substantially flat sides 1.2.8. The guide track 1.2.5 according to the second embodiment has a concave shape and does not pass completely through the flat side 1.2.8.
Needle shield 1.1 has an opening at the proximal end comprising a profile corresponding to the cross-section of support 1.2 with two generally flat sides 1.2.8. Needle shield 1.1 is dimensioned to substantially accommodate support 1.2. When the needle shield 1.1 is moved from the initial position I to the retracted position II, the support body 1.2 slides into the needle shield 1.1.
The flexible arm 1.1.4 is arranged in the hollow needle shield 1.1 so that it cannot be accessed from the outside. The distal end of the flexible arm 1.1.4 is connected to the distal end of the needle shield 1.1. The flexible arm 1.1.4 extends substantially parallel to the central axis A in its unbiased position. The guide pin 1.1.3 extends from the proximal end of the flexible arm 1.1.4 into the guide track 1.2.5 in the radially inward direction. The flexible arm 1.1.4 has a needle shield 1.1 such that it allows a substantially flat movement of the guide pin 1.1.3 when it is offset when using the injection device D. Connected to During the injection, the guide pin 1.1.3 moves along the guide track 1.2.5 formed on the substantially flat side 1.2.8 of the support 1.2.
The proximal end of the support body 1.2 is housed within the open distal end of the outer body 1.3, where the outer body 1.3 is substantially within the outer body 1.3. It is slidable distally with respect to the support body 1.2 so as to receive the support body 1.2. The outer body 1.3 has a shape corresponding to the shape of the support body 1.2 and two substantially flat outer parts opposite the two substantially flat side parts 1.2.8 of the support body 1.2. 1.3.5.
A hand flange 1.3.1 projecting outward in the circumferential direction is integrally formed on the outer surface of the outer body 1.3 close to its distal end.
The skin contact surface 1.1.1 of the needle shield 1.1 is adapted to be pressed against the patient's skin. The skin contact surface 1.1.1 has a central opening dimensioned to coincide with the outer diameter of the needle cap 2.2 of the syringe 2 filled with medicine held in the safety device 1, as well as a substantially hollow needle Providing closure of the distal end of shield 1.1.
A second longitudinal tongue 1.2.2 opposing two diameters is formed on the outer surface of each flat side 1.2.8. The second longitudinal tongue 1.2.2 is located adjacent to each guide track 1.2.5 and extends parallel to the central axis A over a certain axial length of the support 1.2. ing. When the needle shield 1.1 is moved from the initial position I to the retracted position II with respect to the support 1.2, each second longitudinal tongue 1.2.2 is the inner surface of the needle shield 1.1. Are accommodated in correspondingly formed grooves (not shown). This prevents jamming of these parts when the support body 1.2 and the needle shield 1.1 are moved relative to each other.
Furthermore, the longitudinal tongue 1.2.2 also acts as a secondary penetration depth limiter to prevent the side body 1.3 from moving far in the distal direction.
The separating wall 1.2.6 is formed on the outer surface of the flat side 1.2.8 of the support body 1.2. The separating wall 1.2.6 extends parallel to the central axis A in the widened section 1.2.5.2 of the guide track 1.2.5.
The separating wall 1.2.6 according to the second embodiment shown in FIG. 7 is not deflectable and remains stationary through the use of the injection device D.
FIG. 8 shows a perspective view of the support body 1.2 according to the second embodiment, which is opened parallel to the central axis A for convenience of explanation. The guide track 1.2.5 has the shape of a recess and the inside of the support 1.2 cannot be accessed from the outside. The outward projection 1.2.3 is received in a longitudinal locking recess 1.3.2 formed on the inner surface of the outer body 1.3.
9A-9E show the details of the guide track 1.2.5 formed on the support 1.2 and the guide pins 1.2.5 in the guide track 1.2.5 according to the second embodiment during injection. 1.3 moves are shown. 9A-9E show the movement of the guide pin 1.1.3 within the guide track 1.2.5 according to the second embodiment, where the separating wall 1.2.6 is stationary through the injection. It remains.
As shown in FIG. 9A, the guide pin 1.1.3 is in the starting position PI at the distal end of the inclined section 1.2.5.1 of the guide track 1.2.5 prior to injection. The needle shield 1.1 is held at the initial position I. In the initial position I, the hypodermic needle 2.1 is surrounded by a needle shield 1.1.
The injection is performed by directing the central axis A approximately perpendicular to the patient's skin. At this time, the skin contact surface 1.1.1 of the needle shield 1.1 rests on the skin surface of the patient and is proximal to the outer body 1.3 on the proximal side of the hand flange 1.3.1. The part is gripped by the user performing the injection. The hand flange 1.3.1 supports the user's hand to perform the injection stroke, when the outer body 1.3 is moved distally towards the patient's skin surface to initiate the injection To do.
The injection is performed in several stages. In the first stage, the support body 1.2 is pushed into the needle shield 1.1 in the distal direction against the biasing force of the compression spring 1.4. As shown in FIG. 9B, the guide pin 1.1.3 leaves its starting position PI and moves along the inclined section 1.2.5.1 of the guide track 1.2.5. Since the distal end of the inclined section 1.2.5.1 is oriented at an acute angle with respect to the central axis A, movement of the guide pin 1.1.3 laterally moves the flexible arm 1.1.4. The guide pin 1.1.3 is biased laterally as a result of the biasing and loading.
The guide pin 1.1.3 abuts against the separating wall 1.2.6 in the lateral direction. The separating wall 1.2.6 remains stationary and guides the guide pin 1.1.3 further in the proximal direction.
When the guide pin 1.1.3 enters the widening section 1.2.5.2 from the start position PI, the separating wall 1.2.6 will allow the guide pin 1.1.3 to enter the end position PIII. Stop.
The guide pin 1.1.3 moves further proximally towards the intermediate position PII and reaches the proximal end of the separating wall 1.2.6, as shown in FIG. 9C. The biased guide pin 1.1.3 passes through the separating wall 1.2.6 in the lateral direction L as shown in FIG. 9D and is biased and loaded into the flexible arm 1 1.4 is at least partially relaxed.
At this point, the end position PIII is accessible so that the id pin 1.1.3 can be reached and the guide pin 1.1.3 is prevented from re-entering the start position PI. In particular, the safety features of the safety device 1 that prevent the reuse of the injection device D are activated.
Before the drug is released through the hypodermic needle 2.1, the needle shield 1.1 is moved further proximally until reaching the retracted position III shown in FIG. 3, whereby the guide pin 1.1 .3 is held in the guide track 1.2.5 at the intermediate position PII. Here, the compression spring 1.4 is sufficiently compressed and fully loaded. When the hypodermic needle 2.1 penetrates the patient's skin, the drug contained in the internal cavity 2.3.1 can be injected in the second stage following the injection.
In the second stage, the outer body 1.3 moves in the distal direction relative to the support body 1.2. At the same time, the piston rod 2.5 interacting with the outer body 1.3 is actuated to move the piston 2.4 in the distal direction and the drug contained in the internal cavity 2.3.1 is injected subcutaneously. It is delivered through the needle 2.1 and under the patient's skin.
Subsequent removal of the safety device 1 causes the needle shield 1.1 and guide pin 1.1.3 to be advanced distally and the needle shield 1.1 is in the advanced position III under the skin of the drug-filled syringe. Surround the needle 2.1. FIG. 9E shows a needle shield that is securely held in the advanced position III by holding the guide pin 1.1.3 in the U-shaped notch of the guide track 1.2.5 defining the end position PIII. 1.1 is shown. Here, reuse of the injection device and / or the safety device 1 is prevented.
The safety device 1 provides a simple mechanism for avoiding needle stick accidents. The injection is performed by a simple linear movement of the outer body 1.3 towards the patient's skin, thus automatically activating safety features that provide needle safety and prevent reuse of the safety device 1.
1 Safety device 1.1 Needle shield 1.1.1 Skin contact surface 1.1.2 First longitudinal tongue 1.1.3 Guide pin 1.1.4 Flexible arm 1.1.5 Trapezoid Cutout 1.2 Support 1.2.1 First longitudinal groove 1.2.2 Second longitudinal tongue 1.2.3 Outward projection 1.2.4 Locking recess 1.2.5 Guide track 1.2.5.1 Inclined section 1.2.5.2 Widened section 1.2.6 Separation wall 1.2.7 Clip 1.2.8 Flat side 1.3 Outer body 1. 3.1 Hand flange 1.3.2 Longitudinal recess 1.3.2.1 First part 1.3.2.2 Second part 1.3.3 Web 1.3.4 Clamp arm 1. 3.4.1 Lock catch 1.3.5 Flat outer side 1.4 Compression spring 2 Drug filled syringe 2.1 Subcutaneous Shooting needle 2.2 Needle cap 2.3 Barrel 2.3.1 Internal cavity 2.3.2 Barrel collar 2.4 Piston 2.5 Piston rod 3 Cap remover 3.1 Clamp means A Center axis D Injection Device L Lateral direction I Initial position II Retraction position III Advance position PI Start position PII Intermediate position PIII End position
An injection device comprising a safety device (1) for a prefilled syringe (2) and a prefilled syringe (2) with a hypodermic needle (2.1) attached to the distal end ( D),
Here the safety device (1)
A hollow support (1.2) for mounting the drug-filled syringe (2) therein,
A hollow needle shield (1.1) slidable relative to the support (1.2), and a guide for guiding the movement of the needle shield (1.1) relative to the support (1.2) Means, comprising
A flexible arm (1.1.4) with a radially extending guide pin (1.1.3),
A guide track (1.2.5) into which the guide pin (1.1.3) enters, and a guide track (1) in a direction parallel to the central axis (A) of the safety device (1) 2.5) separating wall (1.2.6) extending into
Here, when the needle shield (1.1) slides relative to the support (1.2), the guide pin (1.1.3) follows the guide track (1.2.5). To deflect the flexible arm (1.1.4) in a transverse direction (L) perpendicular to the central axis (A) and to guide it along the guide track (1.2.5) The movement of the pin (1.1.3) is guided by the interaction of the flexible arm (1.1.4) and the separating wall (1.2.6);
The pre-filled syringe (2) is held in the support (1.2) of the safety device (1) and the hypodermic needle (2.1) protrudes from the distal end of the support (1.2); On the other hand, the hypodermic needle (2.1) is surrounded by the needle shield (1.1) in the initial position (I) and the advanced position (III) and exposed in the retracted position (II),
Means (1.2.1.1.2.2) for the safety device (1) to prevent relative rotation between the support (1.2) and the needle shield (1.1); Compression spring (1.4) placed in an unenergized state when the shield (1.1) is in the initial position (I)
An injection device (D) comprising:
A flexible arm (1.1.4) is connected to one of the needle shield (1.1) or the support (1.2) and a guide track (1.2.5) is connected to the needle. The injection device (D) according to claim 1, characterized in that it is formed on the other of the shield (1.1) or the support (1.2 ) .
The widening section (1.2.5.2) of the guide track (1.2.5) in which the separating wall (1.2.6) extends parallel to the central axis (A) of the safety device (1) Injection device (D) according to claim 1 or 2, characterized in that it extends into the injection device (D) .
The separation wall (1.2.6) is the shortest distance that the needle shield (1.1) must move relative to the support (1.2) until the safety device (1) is prevented from being reused. The injection device (D) according to any one of the preceding claims, characterized in that it has an axial dimension extending parallel to the central axis (A), which substantially defines an axial distance.
Audible feedback occurs when the needle shield (1.1) coincides with or exceeds the shortest axial distance with respect to the support (1.2), The injection device (D) according to any one of claims 1 to 4.
The separation wall (1.2.6) is located at the end position (PIII) of the guide pin (1.1.3) in the guide track (1.2.5) from either the distal or proximal direction. ) At this time, allowing the guide pin (1.1.3) to enter the end position (PIII) from the other of the distal or proximal directions The injection device (D) according to any one of claims 1 to 5, characterized by:
The guide track (1.2.5) is formed as a recess in the surface of the support (1.2) or in the surface of the needle shield (1.1). The injection device (D) according to any one of the above.
8. The guide track (1.2.5) according to claim 1, characterized in that it forms an opening in one of the needle shield (1.1) or the support (1.2). The injection device (D) according to item 1.
The separation wall (1.2.6) is flexible and the guide pin (1.1.3) moves along the guide track (1.2.5) to move the separation wall (1.2 .6), whereby the deflection of the flexible separating wall (1.2.6) depends on the deflection of the flexible arm (1.1.4). 9. The injection device (D) according to 8 .
The elasticity of the separating wall (1.2.6) is matched to the elasticity of the flexible arm (1.1.4), and the flexible arm (1.1.6) is deflected by the separating wall (1.2.6). The injection device (D) according to claim 8 or 9, characterized in that it is deflectable according to .4).
11. The guide pin (1.1.3) according to claim 1, wherein the guide pin (1.1.3) is biased laterally (L) by a deflected flexible arm (1.1.4). The injection device (D) according to claim 1 .
12. Injection according to any one of the preceding claims, characterized in that the flexible arm (1.1.4) in the rest position extends essentially parallel to the central axis (A). Device (D) .
13. The guide track (1.2. 5) comprises an inclined section (1.2.5.1) oriented obliquely with respect to the central axis (A). The injection device (D) according to any one of the above.
The needle shield (1.1) is held in the inclined section (1.2.5.1) of the guide track (1.2. 5) in the starting position (PI) (1. 5). 1.3), held in the initial position (I), while in the initial position (I), the needle shield (1.1) projects distally from the support (1.2) The injection device (D) according to any one of claims 1 to 13.
The needle shield (1.1) is movable from the initial position (I) to the retracted position (II) and further to the advanced position (III), while in the initial position (I) and the advanced position (III) The injection device (D) according to any one of claims 1 to 14 , characterized in that the needle shield (1.1) protrudes from the support (1.2 ) .
Means for preventing relative rotation between the support (1.2) and the needle shield (1.1) include a first longitudinal groove (1.2.1) and a first longitudinal tongue (1). The injection device (D) according to any one of claims 1 to 15 , characterized in that it comprises (1.1.2).
JP2013517172A 2010-07-02 2011-06-21 Safety devices for drug-filled syringes and injection devices Active JP5938402B2 (en)
JP2013529988A JP2013529988A (en) 2013-07-25
JP5938402B2 true JP5938402B2 (en) 2016-06-22
JP2013517172A Active JP5938402B2 (en) 2010-07-02 2011-06-21 Safety devices for drug-filled syringes and injection devices
CN107206187A (en) * 2015-01-30 2017-09-26 泰尔茂株式会社 Protector and medical instrument assembly
US20190030249A1 (en) * 2016-03-16 2019-01-31 Eli Lilly And Company Trigger assembly for automatic medication injection device
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