Cannula Tip Protector
Patent Information
- Application Number
- JP2023572564
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-05-25
- Filing Date
- 2022-05-25
- Publication Date
- 2025-05-27
AI Technical Summary
Subretinal injection procedures require precise handling of fine-tipped needles that are susceptible to bending or breakage due to their fragility, posing challenges in accurately delivering fluids to the back of the eye.
A cannula tip protector assembly for Luer-type syringes featuring a protective sleeve that slides over the needle tip, allowing it to be covered or exposed as needed, providing protection and improved visibility during the procedure.
Enhances needle safety and accuracy during subretinal injections by protecting the needle tip from damage while facilitating precise placement and injection.
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Abstract
Description
[Technical field]
[0001] The present invention relates to a cannula tip protector assembly for a Luer type syringe comprising a Luer connector having a needle with a first diameter and a needle tip having a second diameter smaller than the first diameter, where the needle tip is attached in fluid communication to the needle at an end of the needle opposite the Luer connector, and a protective sleeve slidably positioned over the needle and the needle tip. [Background technology]
[0002] U.S. Patent Application Publication No. 2014 / 0128896 discloses a small gauge surgical instrument having a support device, which is a sleeve that can be shifted in and out of the handle of the instrument to provide support at various locations along the flexible tip of the instrument or along predetermined portions of the flexible tip of the instrument.
[0003] European Patent Publication EP-A-1 955 684 discloses a surgical probe having a retractable reinforcing sleeve that can be used with a trocar cannula positioned in the eye. When the probe is inserted into the eye through the trocar cannula, the trocar cannula is removably attached to the distal end of the sleeve, thus acting as a reinforcing device. As the probe tip is advanced into the eye, the sleeve slides back into the probe handle. Summary of the Invention
[0004] SUMMARY OF THE PRESENT EMBODIMENTS The present invention aims to provide an improved cannula tip protector assembly for a Luer type syringe.
[0005] According to the present invention there is provided a cannula tip protector assembly as defined above, further comprising a cannula tip protector actuator unit comprising a luer connector fitting and a protective sleeve connector, the cannula tip protector actuator unit being arranged to move the protective sleeve from a first position in which the needle tip is covered by the protective sleeve to a second position in which the needle tip is exposed outside the protective sleeve. These features may provide improved needle tip protection, for example for safe and accurate performance of subretinal injection procedures.
[0006] The invention will be discussed in more detail below with reference to the accompanying drawings. [Brief description of the drawings]
[0007] [Figure 1A] FIG. 1A shows a perspective view of a cannula tip protector assembly according to one embodiment of the present invention. [Figure 1B] FIG. 1B illustrates a perspective view of a cannula tip protector assembly according to one embodiment of the present invention. [Figure 2A] FIG. 2A shows a side view of a cannula tip protector assembly according to a further embodiment of the present invention. [Figure 2B] FIG. 2B shows a side view of a cannula tip protector assembly according to a further embodiment of the present invention. [Figure 3A] FIG. 3A shows a side view of a cannula tip protector actuator unit according to three exemplary embodiments of the present invention. [Figure 3B] FIG. 3B shows a side view of a cannula tip protector actuator unit according to three exemplary embodiments of the present invention. [Figure 3C] FIG. 3C shows a side view of a cannula tip protector actuator unit according to three exemplary embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0008] Subretinal injection is a procedure that delivers fluid to the rear of the eye, typically to an injection site in or behind the retinal tissue, for example for the purpose of delivering drugs or other substances. In such a procedure, a syringe (or syringes) with a fine-tipped needle is inserted (usually via a trocar) into the eyeball, e.g., the posterior chamber, thereby penetrating several layers of tissue. Fluid is delivered to the injection site through the tip of the needle, e.g., using a conventional syringe configuration.
[0009] Such subretinal injection procedures require steady handling to precisely penetrate the eyeball and manipulate the fragile needle and tip to access the area behind the retina, However, to deliver the fluid accurately and safely, the needle tip can have a very small diameter and, due to its fragility, is susceptible to bending or breaking, for example.
[0010] It is therefore desirable to provide an improved instrument that allows a user to accurately insert and penetrate a needle into the eye to deliver fluid, and yet provides sufficient protection thereof, thereby allowing the user to handle the syringe in an excellent manner to perform a subretinal injection procedure in a safe (and ergonomic) manner.
[0011] SUMMARY OF THE DISCLOSURE Embodiments of the present invention provide a cannula tip protector assembly for a Luer type syringe that provides improved needle protection for performing, for example, subretinal injection procedures.
[0012] 1A-1B show side views of a cannula tip protector assembly 1 for a Luer syringe according to one embodiment of the present invention. In the illustrated embodiment, the cannula tip protector assembly 1 comprises a Luer connector 2 having a needle 3 with a first diameter and a needle tip 4 with a second diameter smaller than the first diameter, where the needle tip 4 is fluidly attached to the needle 3 on the needle opposite the Luer connector 2. That is, as known to those skilled in the art, at least a portion of the needle tip 4 may be disposed within the needle, where the needle is in fluid communication with the Luer syringe to deliver fluid to the needle tip 4. The Luer connector 2 is disposed to connect to the end of the Luer syringe.
[0013] In the embodiment shown in FIGS. 1A-1B, the cannula tip protector assembly 1 further comprises a protective sleeve 5 slidably positioned over the injection needle and needle tip 4 . The protective sleeve 5 may cover at least a part of the injection needle 3 and at least a part of the needle tip 4, i.e. cover their outer surface area from (direct) exposure to the external environment.
[0014] The protective sleeve 5 has a length arranged to protect the injection needle 3 and the needle tip 4, where, as mentioned above, the injection needle 3 and especially the needle tip 4 are susceptible to e.g. breakage or bending due to their fragility and small diameter. The protective sleeve 5 therefore provides suitable protection for the injection needle 3 and the needle tip 4, and is also strong enough to be inserted into and penetrate the eye or a trocar present on the eye. The protective sleeve 5 can comprise any suitable material known to the skilled person, for example a metal (e.g. stainless (surgical) steel or titanium), or a (strong) plastic material.
[0015] Further, in this embodiment (as shown in Figures 1A-1B), the cannula tip protector assembly 1 further comprises a cannula tip protector actuator unit 10 comprising a luer connector fitting 11 and a protective sleeve connector 12, the cannula tip protector actuator unit 10 being arranged to move the protective sleeve 5 from a first position where the needle tip 4 is covered by the protective sleeve 5 to a second position where the needle tip 4 is exposed outside the protective sleeve 5, the first position being shown in Figure 1A and the second position being shown in Figure 1B. The luer connector fitting 11 may be attached to a portion of the luer connector 2 and the protective sleeve connector 12 may be attached to a portion of the protective sleeve 5. It should be noted that in the first position, the needle tip 4 is completely covered by the protective sleeve 5.
[0016] The protective sleeve connector 12 may be connected in a number of ways to a portion of the protective sleeve 5. For example, the protective sleeve 12 may be melted and / or glued to the protective sleeve 5 for its robust connection. Alternatively, the protective sleeve 12 may comprise, for example, a ring-shaped element and be tightly threaded onto the protective sleeve 5 (e.g., using friction for its secure connection).
[0017] By leaving the luer connector fitting 11 fixed in place on the luer connector 2 and moving the protective sleeve connector 12 in a direction towards the luer connector 2 (e.g., by pulling it back), the protective sleeve 5 moves in tandem from a first position to a second position as shown in the embodiment of Figures 1A-1B. Thus, by using the cannula tip protector actuator unit 10, a user can choose to cover the needle tip 4 by moving the protective sleeve 5 away from the luer connector 2 (i.e., the first position) or expose the needle tip 4 by allowing the protective sleeve 5 to move towards the luer connector 2 (i.e., the second position). In this regard, the needle tip 4 may be protected by the protective sleeve 5 or exposed, as desired by the user.
[0018] More generally, embodiments of the present invention relate to a cannula tip protector assembly 1 for a Luer type syringe comprising a Luer connector having a needle 3 with a first diameter and a needle tip 4 with a second diameter smaller than the first diameter, as described herein, where the needle tip 4 is attached in fluid communication to the needle at an end of the needle opposite the Luer connector 2. The cannula tip protector assembly 1 further comprises a protective sleeve 5 slidably positioned over the needle and the needle tip 4, and a cannula tip protector actuator unit 10 comprising a Luer connector attachment 11 and a protective sleeve connector 12, the cannula tip protector actuator unit 10 being arranged to move the protective sleeve 5 from a first position where the needle tip 4 is covered by the protective sleeve 5 to a second position where the needle tip 4 is exposed outside the protective sleeve 5. This can provide an improved cannula tip protector assembly 1 for a Luer type syringe that provides improved protection of the needle tip 4 for safely and accurately performing, for example, a subretinal injection procedure.
[0019] A further possible advantage of embodiments of the present invention is that the cannula tip protector assembly 1 is easily compatible with (and can be easily attached to) a wide range of Luer syringes of different sizes, e.g., standard 5cc Luer syringes, etc. Similarly, a further advantage is that the cannula tip protector assembly 1 is also compatible with injection needles 3 and needle tips of various diameters.
[0020] A further advantage is improved visualization of the needle tip 4. Thanks to the larger diameter, the user can more easily see the protective sleeve 5 (e.g., via a camera) during the procedure, thereby enabling accurate positioning of the protective sleeve 5 relative to the injection site prior to exposing the needle tip 4 for fluid injection.
[0021] The following non-limiting example is presented to detail advantageous features of the cannula tip protector assembly 1 in the context of the embodiments of the invention described herein: The cannula tip protector assembly 1 is attached via a Luer connector 2 to a Luer syringe, where the Luer syringe is provided with a control device for injecting (i.e., outputting) a fluid held within the Luer syringe upon actuation thereof, for example using a foot pedal. The Luer syringe is filled with fluid and the needle tip 4 is attached to the end of the injection needle 3 and in fluid communication with the injection needle 3. During the procedure, the needle tip 4 is first covered by a protective sleeve 5 for its protection (i.e., in a first position) and is inserted, for example, into the posterior chamber of the eyeball and penetrates the retina. The (end of) the protective sleeve 5 is then precisely positioned relative to the injection site (for example by use of a camera) and precisely held in position. Using the cannula tip protector actuator unit 10, the protective sleeve 5 is actuated from the first position to a second position, thereby exposing the needle tip 4 to the injection site. The control device is then actuated via a foot pedal and the fluid held in the Luer syringe is injected through the needle tip 4 to the injection site. After retracting the needle tip 4 from the injection site, the protective sleeve 5 may then be actuated from the second position to the first position to re-protect the fragile needle tip 4 and withdrawn from the eyeball.
[0022] In this regard, the fragile needle tip 4 is protected by the protective sleeve 5 in the first position when being manipulated through the eye. The protective sleeve 5 is also more easily visible during the procedure, allowing for its precise positioning, and can be easily actuated between the first and second positions to expose the needle tip 4 for injecting fluids. In view of this, such a cannula tip protector assembly 1 also fits a variety of Luer syringes and needle tip 4 diameters, thereby providing a cannula tip protector assembly 1 that is easy to use, cost effective, and highly protective.
[0023] In one embodiment, the cannula tip protector actuator unit 10 further comprises a latch mechanism for holding the protective sleeve 5 in the second position. The latch mechanism may comprise any latch mechanism known to one skilled in the art, possible embodiments for which are described below. In general, the latch mechanism provides ease of use of the cannula tip protector actuator unit 10 and allows a user to safely hold the protective sleeve 5 in the second position, for example to perform a subretinal injection procedure in a better and safer manner.
[0024] To this end, in a further embodiment, the second position is a stable position. The stable position allows for safe use of the cannula tip protector assembly 1 and Luer syringe combination since the user can hold the combination securely without significant concern of instability while the protective sleeve 5 is in the second position. For example, with respect to the non-limiting example described above, the protective sleeve 5 is stably held in the second position to expose the needle tip 4 for injecting fluids without significant concern of the protective sleeve 5 becoming unstable and, for example, accidentally activating in the first position.
[0025] 1A-1B, the cannula tip protector actuator unit 10 further comprises an elongated resilient actuator portion 15 connected to the protective sleeve connector 12 by a first hinge connection 16 and to the luer connector attachment portion 11 by a second hinge connection 17. The first and second hinge connections 16, 17 may comprise living hinge connections which provide for easy manufacture of the cannula tip protector assembly 1.
[0026] As shown in Figure 1B, the elongated elastic actuator part 15 may have an arch-shaped shape at "rest" in the second position, i.e. the rest position is a stable position. Actuating the elongated elastic actuator part 15 in the "rest" second position, for example by pressing a finger against a portion thereof, causes a "deformation" of the arch-shaped shape of the elongated elastic actuator part 15 (see Figure 1A) and actuates the protective sleeve 5 from the second position to the first position.
[0027] In this way, the elongated elastic actuator portion 15 not only provides a simple connection between the luer connector fitting portion 11 and the protective sleeve connector 12, but also provides simple and easy actuation of the protective sleeve 5 between the first and second positions.
[0028] With this in mind, in a further exemplary embodiment, the elongated resilient actuator portion 15 has a length that is greater than the distance between the protective sleeve connector 12 and the luer connector fitting 11 in the second position, which distance is greater in the first position than in the second position, as shown in Figures 1A-1B. By having a length that is greater than the distance in the second position, this allows the elongated resilient actuator portion 15 to have a sufficient length to have an arched shape in the second position and have proper actuation of the protective sleeve 5 between the first and second positions.
[0029] In yet another embodiment shown in Figures 1A-1B, the luer connector attachment part 11 comprises a luer connection ring 18 and an actuation surface 19 extending in a direction away from the injection needle, and the second hinge connection part 17 is located at an end of the actuation surface 19 remote from the luer connection ring 18. In this embodiment, the luer connector 2 may be pushed or screwed through the luer connection ring 18 for its easy attachment. Furthermore, in this embodiment, (one end of) the elongated elastic actuator part 15 is connected to the end of the actuation surface 19 by the second hinge connection part 17.
[0030] 1A, in a first position, the elongated resilient actuator portion 15 contacts the surface of the luer connection ring 18, thereby "informing" the user that the needle tip 4 is covered and protected by the protective sleeve 5. In a second position, as shown in FIG. 1B, the elongated resilient actuator portion 15 has an "arcuate" like shape in the "rest" state, thereby "informing" the user that the needle tip 4 is exposed.
[0031] In this regard, the presence of the luer connection ring 18 and actuation surface 19 allows for easy use of the cannula tip protector actuator unit 10. A user may simply tap or press, for example with a finger, the "arcuate" shape of the "resting" elongated resilient actuator portion 15 to come into (direct) contact with the luer connection ring 18 for the appropriate actuation movement.
[0032] In this regard, the length of the actuating surface 19 may relate to the use of the cannula tip protector assembly 1 with different Luer syringes, for example, a wider Luer syringe may include a shorter actuating surface 19 for a proper Luer connection, and vice versa.
[0033] With this in mind, in a further embodiment, both the first and second positions are stable positions. This provides a bi-stable operation of the cannula tip protector actuator unit 10, allowing even better stability during use of the cannula tip protector assembly 1. Also, with respect to the non-limiting example described above, the protective sleeve 5 may be stably held in the first position for manipulation and penetration into the eye, then actuated and stably held in the second position for injecting fluid through the exposed needle tip 4, and then re-actuated and stably held in the first position for withdrawal from the eye. This details various advantages of having both the first and second positions as stable positions, and one skilled in the art will appreciate such advantages in stably and safely performing careful and cautious movements, for example in a subretinal injection procedure.
[0034] 2A-2B show side views of a cannula tip protector assembly 1 for a Luer syringe according to one embodiment of the present invention. Elements having the same function as in the exemplary embodiment shown in Figures 1A and 1B are indicated by the same reference numerals.
[0035] 2A-2B, the cannula tip protector actuator unit 10 further comprises an articulating actuator part assembly 20, 21 connected to the protective sleeve connector 12 by a first hinge connection 16 and to the luer connector attachment part 11 by a second hinge connection 17. The articulating actuator part assembly 20, 21 comprises parts connected by one or more joints for well articulating actuation of the protective sleeve 5 between a first position and a second position, thereby allowing simple and easy actuation of the protective sleeve 5.
[0036] In a further embodiment, the articulated actuator assembly 20, 21 comprises a first linear arm 21 and a second linear arm 20 interconnected by a third hinge connection 24, with the first linear arm 21 connected to the protective sleeve connector 12 by a first living hinge connection 16 and the second linear arm 20 connected to the luer connector fitting 11 by a second hinge connection 17, as shown in Figures 2A-2B. Similar to the first and second hinge connections 17, 18 already described herein, the third hinge connection 24 may also comprise a living hinge connection. In this embodiment, the ends of the first linear arm 21 and the second linear arm 20 are connected via the third hinge connection 24, as shown in Figures 2A-2B.
[0037] As shown in Figure 2A, in this embodiment, the first straight arm 21 and the second straight arm 20 form an extended straight arm in which the protective sleeve 5 is in a first position. As shown in Figure 2B, in this embodiment, the first straight arm 21 and the second straight arm 20 form a curved shape, for example a (substantially) V-shaped curvature, in which the protective sleeve 5 is in a second position, in which the third hinge connection 24 is the apex of the curvature.
[0038] In this regard, the second straight arm 20 may be provided with a finger support surface 22 arranged for auxiliary actuation of the protective sleeve 5, the finger support surface 22 being provided, for example, at the end of the second straight arm 20 opposite the third hinge connection 24.
[0039] Further, in this embodiment, as shown in Figures 2A-2B, the second straight arm 20 may be connected to the luer connector fitting 11 by the second hinge connection 17 via a connection tab 23. In other words, the luer connector fitting 11 comprises a connection tab 23 with a second hinge connection 17 for connection with the second straight arm 20.
[0040] Generally, the embodiment shown in Figures 2A to 2B having an articulated actuator part assembly 20, 21 with a first linear arm 21 and a second linear arm 20 has a compact and efficient arrangement of (mechanical) parts, where the parts are well assembled to form a suitable assembly, have an aesthetically pleasing appearance, and further enable proper actuation of the protective sleeve 5 between the first and second positions.
[0041] In the particular embodiment shown in Figures 2A-2B, with reference to the embodiments described for the latch mechanism above, the latch mechanism comprises cooperating latch elements 25, 26 on the luer connector attachment 11 and on the second linear arm 20. As shown in the embodiment of Figures 2A-2B, the cooperating latch elements 25, 26 can comprise a first latch element 25 provided on the second linear arm 20, e.g., near the end of the second linear arm 20 remote from the third hinge connection 24, and a second latch element 26 provided on the luer connector attachment 11. The first and second latch elements 25, 26 can both include hook-shaped segments, as shown in Figures 2A and 2B.
[0042] The presence of the cooperating latch elements 25, 26 enables the user to easily hold the protective sleeve 5 in the second position using appropriate and secure fastening means, and further enables the user to easily unlatch the cooperating latch elements 25, 26 to actuate the protective sleeve 5 from the second position to the first position by simply pressing the third hinge connection 24.
[0043] Further, with reference to Figure 2A, a user can, for example, simply press a finger down on the end of the second linear arm 20 (to apply a torque-like force to one side of the second hinge connection 17) to actuate the protective sleeve 5 from a first position to a second position until the elements of the cooperating latch elements 25, 26 latch (and couple) together to securely fasten, where the protective sleeve 5 is held in the second position by the latch mechanism, as shown in Figure 2B. To achieve that effect, the second linear arm 20 is rigid by design (by appropriate selection of materials and dimensions) to allow for forces to be applied to points along its length.
[0044] In view of the above, the above features may be used to describe several non-limiting embodiments of the latch mechanism, and several configurations can be envisioned.
[0045] Accordingly, Figures 3A-3C show side views of a cannula tip protector actuator unit 10 according to three "latch mechanism" embodiments of the present invention.
[0046] 3A shows a side view of the cannula tip protector actuator unit 10 having a "spring"-like embodiment of the latch mechanism. In the "spring"-like embodiment shown in FIG. 3A, the cooperating latch elements 25, 26 include a first latch element 25 at the end of the second linear arm 20 opposite the third hinge connection 24, and a second latch element 26 at the end of the actuation surface 19 remote from the luer connection ring 18 and comprising a hook-shaped segment. By depressing the end of the second linear arm 20, i.e., the first latch element 25, the hook-shaped segment of the second latch element 26 can latch (and couple) to the end of the second linear arm 20 to provide a secure fastening thereof.
[0047] 3B shows a side view of the cannula tip protector actuator unit 10 with a "hook and eye" embodiment of the latch mechanism. In the "hook and eye" embodiment shown in FIG. 3B, the cooperating latch elements 25, 26 include a first latch element 25 on a portion of the second linear arm 20 and a second latch element 26 on an end of the actuation surface 19 remote from the luer connection ring 18, where the first latch element 25 includes an opening and the second latch element 26 includes a hook-shaped segment. By depressing the end of the second linear arm 20, the hook-shaped segment of the second latch element 26 can pass through the opening of the first latch element 25 and latch (and couple) to a surface of the second linear arm 20 for secure fastening thereof.
[0048] 3C shows a side view of the cannula tip protector actuator unit 10 with a "double hook" embodiment of the latch mechanism similar to the embodiment of FIGS. 2A-B. In the "double hook" embodiment shown in FIG. 3C, cooperating latch elements 25, 26 include a first latch element 25 provided on a portion of the second straight arm 20 and a second latch element 26 provided on an end of the actuation face 19 remote from the luer connection ring 18, where both the first latch element 25 and the second latch element 26 include hook-shaped segments. By depressing the end of the second straight arm 20, the hook-shaped segments of the first and second latch elements 25, 26 can latch (and couple) to one another for secure fastening thereof.
[0049] It is reiterated that the described embodiments of the cannula tip protector actuator unit 10 (as shown in Figures 3A to 3C) are non-limiting examples and that alternative implementations of the features described herein are possible, for example, different cooperating latch elements 25, 26 (e.g., slide segments and / or pin segments) may be envisaged.
[0050] As described herein, the length of actuation surface 19 is relevant for use with different Luer type syringes. In this regard, it is noted that the length of actuation surface 19 shown in the embodiment of Figure 3A is longer than that shown in the embodiments of Figures 3B and 3C. Thus, the cannula tip protector actuator unit 10 shown in the embodiment of Figure 3A may be suitable for narrower (smaller volume) Luer type syringes, while the embodiment of Figures 3B and 3C is suitable for wider Luer type syringes.
[0051] In certain embodiments, the needle tip 4 has a length of 1 to 10 mm, for example to provide a length sufficient to penetrate the retina of the eye. In this sense, the distance between the first and second positions may be, for example, 1 to 10 mm.
[0052] In a further particular embodiment, the injection needle has a length of 1 to 5 cm, for example providing a length sufficient to reach the posterior chamber of the eye. In this sense, the injection needle 3 may have a length equal to or greater than the needle tip 4, for example.
[0053] In an advantageous embodiment, the protective sleeve 5 has a diameter of 23G or less, such as 25G or even 27G, so that the protective sleeve 5 has sufficient strength and rigidity for subretinal injections and other ophthalmic applications, and can withstand the forces and tolerances, such as when inserting the protective sleeve 5 into the eye, and resist bending. Furthermore, such a diameter of 23G or less (25G or 27G) is also suitable for use with trocars and causes less trauma than the larger gauge needles / sleeves currently used.
[0054] In a further advantageous embodiment, the needle tip 4 has a diameter of 25G or less, for example 29G or even 41G, for example to provide a needle tip 4 that is particularly suitable for subretinal injection procedures, thereby improving its use. In particular, a diameter of less than 29G, for example 41G, provides good capabilities for delicate manipulation and guidance of the needle tip 4 during subretinal injection procedures.
[0055] Alternatively, an embodiment is provided with a needle tip 4 of 25G diameter, for example in the form of a silicone tube attached to an injection needle 3 with a diameter of 23G. In a further embodiment, injection needles of diameter 23G, 25G or 27G can be provided with a needle tip 4 in the form of a silicone tube that fits inside the end of the injection needle 3. These embodiments are particularly suitable for backflush applications to remove fluids from inside the eye and very close to delicate tissues such as the retina. The small dimensions and soft tip design reduce the risk of causing trauma to nearby tissues. The silicone material needle tip 4 may be a straight tube variant or a "brush" type variant (as known to those skilled in the art) to further reduce the risk.
[0056] To perform such subretinal injection procedures in a safer manner, in a further advantageous embodiment, the needle tip 4 comprises a plastic material, such as PTFE. This may allow the needle tip 4 to be small enough and yet strong enough to deliver fluids therethrough. The needle tip 4 may comprise a plastic material comprising any medical grade material, such as, for example, nylon, silicone, or silicone rubber. In certain embodiments, the needle tip 4 may comprise a single material, i.e., be made from a single plastic material.
[0057] In one embodiment, the cannula tip protector actuator unit 10 is a single component, e.g., an injection molded element. Alternatively stated, for any one of the embodiments described herein, the cannula tip protector actuator unit 10 (as a whole) is formed using an injection molding process to form a single component. Such an injection molding process is not only efficient and highly repeatable in providing the cannulation tip protector actuator unit 10 (i.e., facilitating the manufacturing process), but also allows its features and (mechanical) parts to be connected to form an integral component for easier and improved actuation thereof.
[0058] It should be noted that any of the cannula tip protector actuator units 10 disclosed herein, such as those shown in Figures 1A-1B, 2A-2B, and 3A-3C, may be provided as separate components and may be useful in any application involving subretinal injection procedures without utilizing the cannula tip protector assembly 1 disclosed herein.
[0059] The invention has been described above with reference to several exemplary embodiments as shown in the drawings. Modifications and alternative implementations of several parts or elements are possible and fall within the scope of protection defined in the appended claims.
Claims
1. A cannula tip protector assembly (1) for a lure-type syringe, comprising a luer connector (2) having an injection needle (3) with a first diameter and a needle tip (4) with a second diameter smaller than the first diameter, wherein the needle tip (4) is fluidly connected to the injection needle at the end of the injection needle (3) opposite to the luer connector (2), a protective sleeve (5) slidably positioned over the injection needle (3) and the needle tip (4), and a cannula tip protector actuator unit (10) comprising a luer connector attachment portion (11) and a protective sleeve connector (12), the cannula tip protector actuator unit (10) being arranged to move the protective sleeve (5) from a first position where the needle tip (4) is covered by the protective sleeve (5) to a second position where the needle tip (4) is exposed outside the protective sleeve (5).
2. The cannula tip protector assembly according to claim 1, wherein the cannula tip protector actuator unit (10) further comprises a latch mechanism for holding the protective sleeve (5) in the second position.
3. The cannula tip protector assembly according to claim 1, wherein the second position is a stable position.
4. The cannula tip protector assembly according to claim 3, wherein the cannula tip protector actuator unit (10) further comprises an elongated elastic actuator portion (15) connected to the protective sleeve connector (12) by a first hinge connection (16) and to the luer connector attachment portion (11) by a second hinge connection (17).
5. The cannula tip protector assembly according to claim 4, wherein the elongated elastic actuator portion (15) has a length greater than the distance between the protective sleeve connector (12) and the luer connector attachment portion (11) in the second position.
6. The luer connector attachment portion (11) includes a luer connection ring (18) and an operating surface (19) that extends in a direction away from the injection needle, and the second hinge connection portion (17) is positioned at an end of the operating surface (19) that is away from the luer connection ring (18). The cannula tip protector assembly according to claim 4.
7. The cannula tip protector assembly according to claim 2, wherein both the first position and the second position are stable positions.
8. The cannula tip protector actuator unit (10) further includes an articulated actuator unit assembly (20, 21) connected to the protective sleeve connector (12) by a first hinge connection portion (16) and connected to the luer connector attachment portion (11) by a second hinge connection portion (17). The cannula tip protector assembly according to claim 7.
9. The articulated actuator unit assembly (20, 21) includes a first linear arm (21) and a second linear arm (20) interconnected by a third hinge connection portion (24). The first linear arm (21) is connected to the protective sleeve connector (12) by the first hinge connection portion (16), and the second linear arm (20) is connected to the luer connector attachment portion (11) by the second hinge connection portion (17). The cannula tip protector assembly according to claim 8.
10. The latching mechanism includes cooperating latch elements (25, 26) on the luer connector attachment portion (11) and on the second linear arm (20). The cannula tip protector assembly according to claim 9.
11. The needle tip (4) has a length of 1 to 10 mm. The cannula tip protector assembly according to any one of claims 1 to 10.
12. The injection needle has a length of 1 to 5 cm. The cannula tip protector assembly according to any one of claims 1 to 10.
13. The protective sleeve (5) has a diameter of 23G or less. The cannula tip protector assembly according to any one of claims 1 to 10.
14. The needle tip (4) has a diameter of 25G or less. The cannula tip protector assembly according to any one of claims 1 to 10.
15. The cannula tip protector assembly according to any one of claims 1 to 10, wherein the needle tip (4) comprises a plastic material. **Claim 16** The cannula tip protector actuator unit (10) is a single component, the cannula tip protector assembly according to any one of claims 1 to 10.