Safety needle device

Abstract

A safety needle device (1) comprises: a needle seat (10); a needle (20) mounted on the needle seat (10), the needle (20) extending along a longitudinal axis (X-X) between a distal end (21) formed for insertion into a patient's body and an opposite proximal end (22) formed for connection to a container; a protective cover (30) which can slide relative to the needle seat (10) along the longitudinal axis (X-X) and is constrained to rotate around the longitudinal axis (X-X); a housing (40) mounted on the needle seat (10); an elastic member (50) which is arranged in the housing (40) and acts on the protective cover (30); a sleeve (60) which is arranged in the housing (40) and can be rotatably mounted relative to the protective cover (30) and the housing (40) around the longitudinal axis; a locking arrangement structure (70) which comprises a first locking member (71) and a second locking member (72); the safety needle device (1) comprises a guide arrangement structure (80).

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a protective device capable of preventing a user from being accidentally or intentionally injured by a needle before and after an injection. Background Art

[0002] Typically, a safety needle device comprises an elongated needle having a first end that can be inserted into the patient's skin and a second end that can be inserted into a container for supplying a substance. The needle is embedded in a needle seat and is partially surrounded by a housing fixed to the needle seat. The known device also includes a protective cover that surrounds the needle and moves along the needle. The first end of the protective cover points to the outside of the housing, and the second end moves inside the housing and points to the needle seat. A spring is configured between the protective cover and the needle seat so that the protective cover is constantly pushed toward the first end of the needle. Specifically, during injection, the protective cover is pushed toward the second end of the needle in the housing, thereby compressing the spring, and then in the process of withdrawing the needle from the patient, the spring pushes the protective cover toward the first end of the needle. In order to prevent further use or injury, the device includes a locking means that can lock the sliding of the protective cover after injection.

[0003] An example of a safety needle device is disclosed in patent application WO2019156579A1 under the name of the present applicant. This device includes a rotating sleeve inside the housing, which at least partially surrounds the needle. Specifically, the protective cover and the rotating sleeve cooperate to lock the protective cover to prevent further use or injury. In detail, at least the second end of the protective cover is inserted into the rotating sleeve, and the pin protruding from the outer surface of the protective cover engages with the groove formed in the rotating sleeve. Initially, the pin is configured in a first span (bay) formed in the groove, which allows the longitudinal movement of the protective cover. During injection, the protective cover slides in the rotating sleeve, thereby causing the first rotation of the sleeve, and then during extraction, the protective cover is at least partially pushed to the outside of the sleeve by the spring, thereby causing the second rotation of the sleeve. The rotation allows the pin to be routed from the first span to the second span, locking the pin to prevent the protective cover from further longitudinal movement.

[0004] However, known safety needle devices show some disadvantages. In fact, such devices do not ensure that the user is properly protected from further use and accidental injuries. In addition, known devices are complex and require many components to achieve the result, which increases the overall cost of production and design.

[0005] It should also be noted that the device disclosed in WO2019156579 A1 for preventing the protective cover from rotating during injection has ribs formed on the needle seat, which are engaged by the protective cover when the protective cover enters the rotating sleeve during injection. If not correctly aligned with the corresponding grooves on the protective cover, these ribs will prevent the longitudinal movement of the protective cover, making the device unusable. Summary of the invention

[0006] In this context, the underlying technical task of the present invention is to propose a safety needle device that overcomes the above-mentioned disadvantages of the prior art.

[0007] In particular, it is an object of the present invention to provide a safety needle device which is able to ensure protection for the user and at the same time improve the usability of the device itself.

[0008] The proposed technical task and the specific purpose are substantially achieved by means of a protective cap interposed between the housing and the sleeve surrounding the needle seat. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The invention will now be explained in more detail hereinafter with reference to the accompanying drawings, in which some embodiments of the invention are shown.

[0010] Figure 1 is a first cross-sectional view of a safety needle device according to an embodiment of the present invention;

[0011] Figure 2 is a second cross-sectional view of a safety needle device according to an embodiment of the present invention;

[0012] Figure 3 yes Figure 1 and Figure 2 A cross-sectional view of the safety needle pen during the first stage of injection;

[0013] Figure 4 yes Figure 1 and Figure 2 A cross-sectional view of the safety needle pen during the second stage of injection;

[0014] Figure 5 yes Figure 1 and Figure 2 A cross-sectional view of the safety needle pen during the third stage of injection;

[0015] Figure 6 yes Figure 1 and Figure 2 A cross-sectional view of a safety needle pen in a locked configuration;

[0016] Figure 7 yes Figure 1 and Figure 2 Cross-section of the safety needle pen in the locked configuration. DETAILED DESCRIPTION

[0017] Reference Figures 1 to 7 , the safety needle device is indicated as a whole by the number 1. The safety needle device can be associated with a container containing a substance to be injected into a patient's body or containing blood drawn from a patient.

[0018] The safety needle device 1 comprises a hub 10 configured to be connected to a container and a needle 20 connected to the hub 10. The needle 20 extends along a longitudinal axis XX between a distal end 21 formed to be inserted into a patient and an opposite proximal end 22 formed to be connected to a container.

[0019] The safety needle device 1 comprises a protective cover 30, which can slide along the longitudinal axis XX relative to the needle holder 10 between an initial position before injection and a locked position after injection through an intermediate position. Specifically, during the process of injecting the needle into the patient's body, the protective cover 30 slides along the longitudinal axis XX toward the proximal end 22 of the needle 10 from the initial position to the intermediate position. Conversely, during the process of withdrawing the needle from the patient, the protective cover 30 slides along the longitudinal axis XX toward the distal end 21 of the needle 10 from the intermediate position to the locked position.

[0020] According to a preferred embodiment, the protective cover 30 is configured to cover and protect the distal end 21 of the needle in both the initial position and the locked position. Specifically, the protective cover 30 is configured to be locked in the locked position to avoid further sliding after injection to expose the distal end 21 of the needle.

[0021] Preferably, the protective cover 30 is rotationally constrained about the longitudinal axis XX.

[0022] More preferably, the protective cover 30 comprises a tubular body 33 extending along the longitudinal axis XX and defining a through passage 34 through which at least part of the needle hub 10 is inserted.

[0023] It should be noted that the protective cover 30 has an inner surface 31 facing inwardly toward the needle hub 10 and an opposite outer surface 32 facing outwardly. Specifically, the tubular body 33 has an inner surface 31 facing the through passage 34.

[0024] According to one embodiment, the protective cover 30 has a mark 36 on the outer surface 32, and the mark 36 is configured to indicate the use state of the safety needle device. Specifically, the mark 36 is formed so that the mark 36 is visible when the protective cover 30 passes from the initial position to the locking position.

[0025] The safety needle device 1 includes a housing 40, which is attached to the needle seat 10 and surrounds a portion of the needle seat 10. When the protective cover 30 is in the initial position and the locked position, the housing 40 surrounds a portion of the protective cover 30; when the protective cover 30 is in the intermediate position, the housing 40 surrounds almost all of the protective cover 30, preferably surrounds all of the protective cover 30. Preferably, the housing 40 includes a tubular body 43 having a through channel 44. Specifically, in the initial position, the protective cover 30 is at least partially inserted into the through channel; and in the intermediate position, the protective cover 30 is almost completely, preferably completely, inserted into the through channel. In detail, the protective cover 30 includes a first length portion inserted into the through channel in the initial position, and a second length portion inserted into the through channel in the locked position, wherein the first portion is equal to or longer than the second portion. The protective cover 30 also includes a third length portion inserted into the through channel in the intermediate position, wherein the third portion is longer than the first length portion and the second length portion. Preferably, the third length portion is equal to the length of the protective cover 30.

[0026] Preferably, the housing 40 has an inner surface 41 facing at least part of the protective cover 30 and an opposite outer surface 42 facing outwards. More preferably, the inner surface 41 of the housing 40 partially faces the outer surface 33 of the protective cover 30. It is noted that the tubular body 43 has the inner surface 41 of the housing 40 facing the through passage 44 of the housing.

[0027] The safety needle device 1 includes a guide arrangement 80 configured to guide the protective cover 30 between the initial position and the locking position along the longitudinal axis XX to prevent the protective cover 30 from rotating relative to the housing 40 and the needle seat 10. Specifically, the guide arrangement 80 includes a first guide member 81 formed on the protective cover 30 and a second guide member 82 formed on the housing 40. In detail, the first guide member 81 is configured to cooperate with the second guide member 82 to guide the protective cover 30 to slide along the longitudinal axis XX and prevent the protective cover 30 from rotating relative to the housing 40.

[0028] Preferably, the first guide member 81 is formed on the outer surface 32 of the protection cover 30 , and the second guide member 82 is formed on the inner surface 41 of the housing 40 .

[0029] More preferably, the second guide member 82 includes a longitudinal groove 83 formed on the inner surface 41 of the housing 40. Specifically, the longitudinal groove 83 is linear and extends along the longitudinal axis XX. Alternatively, the first guide member 81 includes a protrusion 84 protruding from the outer surface 32 of the protective cover 30 and configured to engage with the longitudinal groove 83. This engagement is always maintained from the initial position and the locked position of the protective cover 30.

[0030] Even more preferably, the first guide members 81 are angularly spaced apart on the outer surface 32 of the boot 30 , and the second guide members 82 are angularly spaced apart on the inner surface 41 of the housing 40 .

[0031] The safety needle device 1 includes an elastic member 50 disposed in the housing and acting on the protective cover 30. Preferably, the elastic member 50 is configured to push the protective cover 30 all the way to the distal end 21 of the needle 10. Specifically, the elastic member 50 is biased to push the protective cover 30 toward the distal end 21 of the needle 10, and contrasts with the longitudinal sliding of the protective cover 30 toward the proximal end of the needle 10. In detail, the elastic member 50 is configured to be elastically compressed during the injection process as the protective cover 30 passes from the initial position to the intermediate position, and is configured to be elastically extended during the withdrawal process as the protective cover 30 passes from the intermediate position to the locked position.

[0032] Preferably, the elastic member 50 is interposed between the needle hub 10 and the protective cover 30 so as to constantly push the protective cover 30. Specifically, the needle hub 10 includes a stopper wall 11 configured to accommodate a portion of the elastic member 50. Alternatively, the protective cover 30 includes an annular flange 35 that protrudes from the inner surface 31 of the protective cover 30 and is configured to hold the distal portion 51 of the elastic member 50.

[0033] More preferably, the resilient member 50 extends along the longitudinal axis XX between a distal portion 51 and a proximal portion 52. Thus, the stop wall 11 accommodates the proximal portion 52 of the resilient member 50 and the annular flange 35 accommodates the distal portion 51 of the resilient member 50.

[0034] The safety needle device 1 comprises a sleeve 60 which is arranged in the housing 40 and is rotatably mounted relative to the protective cover 30 and the housing 40 about the longitudinal axis XX. Specifically, the sleeve 60 surrounds at least part of the needle hub 10 and is configured to rotate relative to the needle hub 10 about the longitudinal axis XX.

[0035] Specifically, the sleeve 60 has an inner surface 61 facing the needle hub 10 and an opposite outer surface 62 facing outwardly toward at least a portion of the inner surface 41 of the housing 40 .

[0036] According to one embodiment, when the protective cover 30 is in the initial position and in the locked position, the protective cover 30 surrounds at least part of the sleeve 60. However, when the protective cover 30 is in the intermediate position, the protective cover 30 almost completely, preferably completely surrounds the sleeve 60. In detail, when the protective cover 30 is in the initial position and the locked position, the sleeve 60 is at least partially inserted into the through passage 34 of the protective cover 30. On the contrary, when the protective cover 30 is in the intermediate position, the sleeve 60 is almost completely, preferably completely inserted into the through passage 34 of the protective cover 30. In more detail, the first length portion and the second length portion of the protective cover 30 at least partially surround the sleeve 60 in the initial position and the locked position, respectively. On the contrary, the third length portion of the protective cover 30 almost completely, preferably completely surrounds the sleeve 60 in the intermediate position, respectively.

[0037] It should be noted that the inner surface 41 of the housing 40 faces at least a portion of the sleeve 60 and the protective cover 30. In addition, the inner surface 31 of the protective cover 30 partially faces the sleeve 60 and the outer surface 32 of the protective cover 30 partially faces the inner surface 41 of the housing 40. Therefore, the inner surface 61 of the sleeve 60 partially faces the needle hub 10, and the opposite outer surface 62 partially faces the inner surface 31 of the protective cover 30 and the inner surface 41 of the housing 40.

[0038] Advantageously, the relationship between the inner surface 31 , 41 , 61 and the outer surface 32 , 42 , 62 is maintained in the initial position, the intermediate position and the locked position of the protective cover 30 .

[0039] According to a preferred embodiment, the elastic member 50 surrounds at least a portion of the sleeve 60. Specifically, the elastic member 50 surrounds the outer surface 62 of the sleeve 60.

[0040] The safety needle device 1 includes a locking arrangement 70 configured to rotate the sleeve 60 and lock the protective cover 30 in a locked position when the protective cover 30 slides. Specifically, the locking arrangement 70 includes at least one first locking member 71 formed on the protective cover 30 and at least one second locking member 72 formed on the sleeve 60. In detail, the first locking member 71 cooperating with the second locking member 72 is configured to rotate the sleeve when the protective cover 30 slides and lock the protective cover 30 in a locked position. Preferably, the first locking member 71 cooperating with the second locking member 72 is configured to rotate the sleeve during the sliding of the protective cover 30 and lock the protective cover 30 in a locked position.

[0041] In more detail, the first locking member 71 cooperates with the second locking member 72 to guide the protective cover 30 from the initial position through the intermediate position to the locked position. In addition, when the protective cover 30 itself reaches the locked position, the first locking member 71 and the second locking member 72 cooperate to lock the protective cover 30 in the locked position.

[0042] Preferably, the first locking member 71 is formed on the inner surface 31 of the protective cover 30 , and the second locking member 72 is formed on the outer surface 62 of the sleeve 60 .

[0043] According to one embodiment, the second locking member 72 includes a slit 73 , and the first locking member 71 includes a pin 74 configured to engage with the slit 73 .

[0044] Preferably, the slit 73 includes a first stopping section 73 a , a second stopping section 73 b , and a locking section 73 c configured to longitudinally limit the sliding of the protection cover 30 .

[0045] Specifically, the first stop segment 73a is configured to engage the pin 74 at the initial position of the protective cover 30 to prevent the protective cover 30 from sliding longitudinally toward the distal end 21 of the needle 20. In contrast, the second stop segment 73b is configured to engage the pin 74 at the intermediate position of the protective cover 30 to prevent the protective cover 30 from sliding longitudinally toward the proximal end 22 of the needle 20. It should be noted that the first stop segment 73a and the second stop segment 73b are configured to limit the travel of the protective cover 30 along the longitudinal axis. In fact, the first stop segment 73a holds the protective cover 30 against the preloaded elastic force of the elastic member 50, which pushes the protective cover 30 toward the distal end 21, while the second stop segment 73b is configured to stop the protective cover 30 at the intermediate position during injection.

[0046] The locking segment 73c is configured to engage the pin 74 in the locked position of the protective cover 30 to prevent the protective cover from sliding longitudinally toward both the distal end 21 and the proximal end 22 of the needle 10. Specifically, the locking segment 73c is configured to hold the pin 74 so as to prevent further use of the safety needle device 1 and sliding of the protective cover along the longitudinal direction. Preferably, the locking segment 73c also limits the travel of the protective cover 30 along the longitudinal axis XX, thereby holding the protective cover 30 against the preloaded elastic force of the elastic member 50, which also continues to force the protective cover 30 toward the distal end 21 in the locked position. More preferably, the locking segment 73c has a "C" shape, which is configured to receive and hold the pin 74, avoiding further sliding of the protective cover 30 when the pin 74 reaches the locking segment 73c.

[0047] According to one embodiment, the slit 73 further includes a first rotation segment 73d and a second rotation segment 73e configured to convert the longitudinal sliding of the protective cover 30 into the rotation of the sleeve 60. Specifically, the first rotation segment 73d and the second rotation segment 73e engage with the pin 74 to rotate the sleeve 60.

[0048] In detail, the first rotation section 73d is configured to engage the pin 74 and rotate the sleeve 60 when the protective cover 30 slides from the initial position toward the intermediate position along the longitudinal axis XX. Alternatively, the second rotation section 73e is configured to engage the pin 74 and rotate the sleeve 60 when the protective cover 30 slides from the intermediate position toward the locking position along the longitudinal axis XX. In other words, the first rotation section 73d provides a first rotation of the sleeve 60 around the longitudinal axis XX during injection, and the second rotation section 73e provides a second rotation of the sleeve 60 around the longitudinal axis XX during withdrawal.

[0049] Preferably, rotation of the sleeve 60 allows passage of the pin from the first stop segment 73 a to the locking segment 73 c to longitudinally lock the protective cover 30 .

[0050] More preferably, the slit 73 further comprises a guide segment 73f configured to engage the pin 74 and prevent the sleeve 60 from rotating for the sliding of the protective cover along at least a portion of the longitudinal axis XX. Specifically, during injection, after a first rotation of the sleeve, the pin 74 engages with the guide segment 73f until the second stop segment 73b reaches an intermediate position of the protective cover 30. Subsequently, during withdrawal, the pin 74 is engaged with the guide segment 73f until it reaches the second rotation segment 73e that allows a second rotation of the sleeve 60.

Claims

1. A safety needle device, comprising: - a needle hub configured to be connected to the container, - a needle attached to the needle hub, the needle extending along a longitudinal axis between a distal end configured for insertion into a patient and an opposite proximal end configured for connection to the container, a protective cover which is slidable along the longitudinal axis relative to the needle holder and constrained to rotate about the longitudinal axis, the protective cover being configured to irreversibly reach the locked position from the initial position through the intermediate position by sliding during injection from the initial position before injection along the longitudinal axis towards the proximal end of the needle to an intermediate position and by sliding during withdrawal from the intermediate position along the longitudinal axis towards the distal end of the needle to a locked position after injection, - a housing attached to the needle hub and surrounding a portion of the needle hub, wherein the housing surrounds a portion of the protective cover when the protective cover is in the initial position and the locked position, and the housing surrounds substantially all of the protective cover when the protective cover is in the intermediate position, - a resilient member disposed within the housing and acting on the shield, the resilient member being biased to urge the shield towards the distal end of the needle in contrast to a longitudinal sliding movement of the shield towards the proximal end of the needle, a sleeve arranged in the housing and mounted rotatably relative to the protective cover and the housing about the longitudinal axis, a locking arrangement comprising at least one first locking member formed on the protective cover and at least one second locking member formed on the sleeve, the first locking member cooperating with the second locking member to: - rotating the sleeve as the protective cover slides, so as to guide the protective cover from an initial position to a locked position; as well as - upon reaching the locked position, locking the protective cover in the locked position, in - when the protective cover is in the initial position and the locked position, the protective cover surrounds at least a portion of the sleeve; when the protective cover is in the intermediate position, the protective cover surrounds almost the entire sleeve, as well as The safety needle device comprises a guide arrangement structure, the guide arrangement structure comprising a first guide member formed on the protective cover and a second guide member formed on the housing, the first guide member cooperating with the second guide member to guide the protective cover to slide along the longitudinal axis and prevent the protective cover from rotating relative to the housing.

2. The safety needle device according to claim 1, characterized in that: - the housing has an inner surface at least partially facing the sleeve and the protective cover and an opposite outer surface; - the protective cover has an outer surface at least partially facing the inner surface of the housing and an inner surface at least partially facing the sleeve; The sleeve has an inner surface at least partially facing the needle hub and an opposite outer surface at least partially facing the inner surface of the protective cover and the inner surface of the housing.

3. The safety needle device according to claim 2, characterized in that: - the first guide member is formed on the outer surface of the protective cover; -The second guide member is formed on the inner surface of the housing.

4. The safety needle device according to claim 2, characterized in that: - the second guide member comprises a longitudinal groove formed in the inner surface of the housing; The first guide member comprises a protrusion protruding from the outer surface of the protective cover and configured to engage with the longitudinal groove.

5. The safety needle device according to claim 2, characterized in that: - the first guide members are angularly spaced apart on the outer surface of the protective cover; - The second guide members are angularly spaced apart on the inner surface of the housing.

6. The safety needle device according to claim 2, characterized in that: - the first locking member is formed on the inner surface of the protective cover; - The second locking member is formed on the outer surface of the sleeve.

7. The safety needle device according to claim 6, characterized in that: - the second locking member comprises a slit; - said first locking member comprises a pin configured to engage with said slit.

8. The safety needle device according to claim 7, characterized in that: The slit comprises: - a first stop section configured to engage with the pin in an initial position of the shield to prevent longitudinal sliding of the shield towards the distal end of the needle; - a second stop segment configured to engage with the pin in an intermediate position of the shield to prevent longitudinal sliding of the shield towards the proximal end of the needle; - a locking section configured to engage with the pin in the locked position of the shield to prevent longitudinal sliding of the shield both towards the distal end and towards the proximal end of the needle.

9. The safety needle device according to claim 7, characterized in that: The slit comprises: a first rotation section configured to engage with the pin and rotate the sleeve when the protective cover slides along the longitudinal axis from the initial position toward the intermediate position, - a second rotation section configured to engage with the pin and rotate the sleeve when the protective cover slides along the longitudinal axis from the intermediate position towards the locking position.

10. The safety needle device according to claim 2, characterized in that: The elastic member surrounds at least a portion of the outer surface of the sleeve, and the elastic member is interposed between the needle seat and the protective cover.

11. The safety needle device according to claim 10, characterized in that: - said elastic member extends along said longitudinal axis between a distal portion and a proximal portion, - the needle hub comprises a stop wall configured to receive a proximal portion of the resilient member; The protective cover comprises an annular flange protruding from the inner surface of the protective cover and configured to retain a distal portion of the elastic member.

12. The safety needle device according to claim 1, characterized in that: The protective cover includes indicia on an outer surface thereof, the indicia being configured to be visible only when the protective cover is in a locked position.

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