Precise needle advancement
By designing an injection device comprising a knob, connector body, and needle hub, and utilizing a multi-step rotation mechanism and spring bias force, precise needle advance and retraction are achieved, solving the problem of difficulty in confirming needle entry into the cavity and improving the accuracy of drug delivery and therapeutic effect.
Patent Information
- Application Number
- CN202480070735.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-09-27
- Filing Date
- 2024-07-11
- Publication Date
- 2026-05-29
AI Technical Summary
When using needles, it is difficult to confirm whether the needle has entered the cavity, resulting in inaccurate drug delivery. In particular, it is difficult to stabilize and accurately advance the needle in micron-level tissue layers, which affects the efficacy of drug treatment.
An injection device is designed, comprising a knob, a connector body, a needle hub, and a cap. The multi-step rotation mechanism of the knob precisely controls the advance and retraction of the needle. Combined with the biasing force of the spring and the sleeve, discrete step advance and retraction are provided to ensure accurate needle insertion and withdrawal.
This technology enables precise needle advance and retraction, ensuring accurate drug delivery to sub-millimeter tissue layers, improving the success rate of drug therapy, and avoiding unnecessary tissue penetration and drug delivery errors.
Smart Images

Figure CN122121914A_ABST
Abstract
Description
Cross-references to related applications
[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 540,880, filed September 27, 2023, the entire contents of which are incorporated herein by reference for any and all purposes. Technical Field
[0002] This disclosure relates generally to methods and systems for penetrating devices with medical applications, and more specifically to systems and methods for precisely advancing a needle into an injection site. Background Technology
[0003] Penetrating devices, such as needles, are commonly used to inject or drain medications into or from body cavities. For example, the suprachoroidal space (SCS) has been explored as a potential site for drug delivery targeting the posterior segment of the eye. The posterior segment is involved in a variety of related diseases that can be treated with medication, and drug delivery via the SCS has proven to be more effective than direct intravitreal injection into the posterior segment. Summary of the Invention
[0004] The inventors recognized that problems arise when the individual using the needle cannot confirm whether the needle has entered the cavity. Securely and precisely inserting a needle into micrometer-level tissue layers is a challenging problem in the field of precise drug delivery, such as delivery to SCS. Determining whether the needle has entered the tissue is crucial for the success of drug therapy, and manually advancing the needle into sub-millimeter-level tissue layers while maintaining a stable injection based solely on feedback from tissue resistance is extremely difficult.
[0005] The various implementation schemes disclosed herein meet the aforementioned requirements.
[0006] One aspect of this disclosure relates to an injection device having: a connector body configured to releasably attach to a syringe; a needle attached to a needle hub; and a knob configured to rotate relative to the connector body to advance and / or retract the needle hub.
[0007] In some embodiments of this disclosure, the injection device may include one or more of the following features: A knob may be configured to advance and / or retract the needle hub in discrete steps. The injection device may also include at least one pin connecting the needle hub and the knob, wherein the knob includes at least one rotating slot receiving the at least one pin, and the at least one pin rotatably secures the needle hub relative to the connector body. The at least one rotating slot may include a distal surface forming a plurality of steps to enable the needle hub to advance and / or retract in discrete steps. The plurality of steps may connect with angled surfaces to allow needle retraction. The injection device may also include a spring configured to bias the at least one pin distally within the at least one rotating slot. The injection device may also include a sleeve received within a cavity of the spring, wherein the sleeve has a distal surface disposed between the spring and the at least one pin. The knob may include a flexible arm with radial protrusions, the connector body including a flange with a plurality of radial grooves, and for each of the discrete steps, the radial protrusion is received in one of the radial grooves. The connector body may be longitudinally secured to the knob. The injection device may further include at least one locking member, wherein the connector body includes a flange, and the at least one locking member engages the flange to prevent the connector body from retracting proximally from the knob. The connector body may have a proximal portion including a first Luer connector configured to releasably attach to a second Luer connector on a distal portion of the syringe. The connector body may include a lumen configured to receive a tip on the distal portion of the syringe, and the knob may include a lumen configured to receive the distal portion of the syringe. The injection device may include a resilient ring between the needle hub and the connector body. The injection device may include a cap disposed above the distal portion of the knob. The cap may be configured to be rotatably secured to the knob upon attachment, such that rotation of the cap causes rotation of the knob. The cap may include at least one protrusion, and the knob may include at least one opening configured to receive at least one protrusion to rotatably secure the cap to the knob. The cap may have a first position in which at least one protrusion extends through at least one opening and into at least one channel of the connector body, thereby rotatably securing the cap, knob, and connector body. The cap may also have a second position in which at least one protrusion extends through at least one opening, thereby rotatably securing the cap and knob and allowing relative rotation of the cap relative to the connector body. The first position may be defined by an inner rib or groove of the cap that engages with a first recess or rib of the connector body, and the second position may be defined by an inner rib or groove of the cap that engages with a second recess or rib of the connector body.
[0008] Another aspect of this disclosure relates to a system comprising: an injection device; and a syringe capable of being releasably attached to the injection device.
[0009] Another aspect of this disclosure relates to a method of assembling an injection device. The method may include: securing a needle to a needle holder; assembling the needle holder into a connector body; inserting at least one rotating pin into at least one rotating slot to rotatably secure the needle holder to the connector body; assembling a spring and a sleeve onto the connector body; assembling the connector body into a knob; longitudinally securing the connector body inside the knob; and assembling a cap onto the knob. Attached Figure Description
[0010] This application will be further understood when read in conjunction with the accompanying drawings. Exemplary embodiments of the subject matter are shown in the drawings for illustrative purposes; however, the subject matter disclosed herein is not limited to the specific methods, apparatus, and systems disclosed. In the drawings: Figure 1 An isometric view of a system comprising a syringe and an injection device for puncturing ocular tissue, according to the present disclosure, is shown.
[0011] Figure 2 It shows Figure 1 A cross-sectional view of the system for puncturing ocular tissue.
[0012] Figure 3 It shows Figure 1 and Figure 2 An exploded view of the injection device.
[0013] Figure 4 It shows Figures 1 to 3 A cross-sectional view of the system.
[0014] Figure 5 It shows Figures 1 to 4 A partially transparent isometric view of the injection device.
[0015] Figure 6 It shows Figures 1 to 5 A longitudinal view of the connector body of the injection device.
[0016] Figure 7 It shows Figures 1 to 6 Side view of the injection system.
[0017] Figure 8 It shows the assembly Figures 1 to 7 A flowchart of the method for using an injection device.
[0018] Various aspects of this disclosure will now be described in detail with reference to the accompanying drawings, wherein, unless otherwise stated, similar reference numerals always refer to similar elements. Detailed Implementation
[0019] This disclosure relates to methods and systems including an injection device having a rotation mechanism for precisely advancing and / or retracting a needle. The rotation mechanism may include a knob rotatable relative to a connector body to longitudinally translate a needle hub relative to the connector body, thereby advancing and / or retracting the needle. Rotation of the knob can be performed in multiple discrete steps, allowing the needle to extend a precise preset distance, thus providing a variable insertion depth. The knob can rotate precisely about a longitudinal axis and is fixed in other degrees of freedom. Therefore, the system's design eliminates unnecessary free movement and rotation of the needle. Rotation can be controlled by a cap having a first position and a second position, the first position rotatably fixing the cap and knob relative to the connector body, and the second position allowing relative rotation of the cap and knob relative to the connector body. A syringe may be attached to the injection device for injecting medication into tissue via the needle and / or aspirating material from tissue via the needle. During and / or after the procedure, the knob can be turned back in the opposite direction to retract the needle and / or recap it, thereby preventing accidental puncture. The change in injection depth can be preset to very precise distance increments, as small as approximately 0.05 mm to 0.2 mm, but not limited to this range, and depends on the application and tissue characteristics, such as stiffness and thickness.
[0020] Figure 1 and Figure 2 A delivery system 10 is shown, including a syringe 100 and an injection device 200 configured to inject medication into tissue of an eye 300 and / or aspirate substance from tissue of the eye. The syringe 100 may include a syringe body 102 and a plunger rod 110. The syringe body may include a syringe barrel extending longitudinally from a proximal end to a distal end. The syringe body 102 may also have a syringe tip 104 on the distal portion of the syringe barrel (e.g., ...). Figure 4 (As shown) and a syringe flange 106 on the proximal portion of the syringe barrel. The syringe barrel may be substantially tubular (e.g., cylindrical) having an inner surface extending longitudinally to define a chamber 108. The chamber 108 may be configured to receive, store, and / or mix medication for dispensing through a distal opening of the syringe tip 104. In some embodiments, the syringe 100 may be filled with medication and packaged as a pre-filled syringe, which is ready for use upon unpacking.
[0021] Drugs may include one or more of small molecules, biologics, or biological products, and are not limited to peptides, proteins, or monoclonal antibodies, or antibody-drug conjugates, or gene therapies. Drugs may be used in viral vector-based gene therapies, and are not limited to adenovirus, lentivirus, or other carrier-based therapies (such as lipid nanoparticles (LNPs), microparticles, hydrogels), aqueous and non-aqueous vector-based therapies, and cell-based drug products. Drugs may be different types of cells (CAR-T cells, neurons, retinal pigment epithelial cells, epidermal cells, fibroblasts, myoblasts, cardiomyocytes, iPSCs, adipose-derived stem cells, mesenchymal stem cells) or their differentiation stages or sources of origin. Cell-based drug products may also include exogenous or other cell-derived drug products, extracellular matrix (ECM) and ECM components (laminarin, collagen, heparin sulfate proteoglycans, actin) or cell assemblies or aggregates, scaffolds, and tissue-engineered pharmaceutical products. In some implementations, the drug may be Lucentis®, Eylea®, Eylea® HD, Syfovre®, Vabysmo®, RGX-314, Izervay®, Lytenava®, or Beovu®, or drugs in the clinical process such as axitinib, RGX-314, ALK-001, AVD-104, ATSN-201, or OPT-302. As the syringe body, a syringe body made of cyclic olefin polymers may be used, such as Crystal Zenith® manufactured by Daikyo Seiko, Ltd.
[0022] As further shown, the eye 300 comprises multiple layers including the sclera 302, choroid 304, and retina 306. A suprachoroidal space (SCS) 308 is disposed between the sclera 302 and the choroid 304. In some embodiments, the present invention relates to injecting a drug into a subanatomical space (such as the SCS 308) to achieve choroidal-retinal concentrations up to 10 times that of conventional intravitreal injections. The injection can have retinal, choroidal, gene therapy, and / or ocular oncology applications. By selectively targeting the posterior segment of the eye, injection into the SCS 308 has the potential to mitigate effects on the anterior segment and thus reduce the rate of increase in intraocular pressure (IOP). Although illustrated in ocular applications, the delivery system 10 is readily adaptable to any number of injections and / or aspiration treatments, for example, where precise needle translation may be required and / or where different tissue stiffness exists on adjacent layers. The SCS 308 is a relatively small space relative to the sclera 302 and some other parts of the eye 300, making it difficult to accurately deliver a drug dose into the SCS 308. An advantage throughout the aspects described in this application is improved control over the desired location of drug delivery into the eye 300 via precise targeting of the SCS 308. The disclosed concepts help to avoid delivering the drug into the sclera 302 before reaching the SCS 308, and / or avoid delivering the drug across the SCS 308 and through the choroid 304 into the choroid.
[0023] like Figures 3 to 7 As shown, the injection device 200 may include a knob 202, a connector body 204, a needle holder 206, a needle 208, and a cap 210. The knob 202 is rotatable relative to the connector body 204 to longitudinally translate the needle holder 206 relative to the connector body 204, thereby advancing and / or retracting the needle 208. As further shown, the knob 202 may have an inner cavity 203 that receives the connector body 204. The needle holder 206 may be received within the inner cavity 205 of the connector body 204, and the needle 208 may be secured to the needle holder 206. The needle holder 206 may have an inner cavity 207 communicating with the inner cavity 205 of the connector body 204. The needle 208 may be rotatably and longitudinally secured to the inner cavity 207 of the needle holder 206, for example, using an adhesive. The connector body 204 may have a distal portion 212 with an opening 214 through which the needle 208 can extend by rotation of the knob 202. The distal portion 212 of the connector body 204 may extend distally out of the cavity 203 of the knob 202 to provide a contact surface to the skin during injection. The distal portion 212 of the connector body 204 may be truncated conical to facilitate operation and / or skin contact. The connector body 204 may have a flange 216 and a proximal portion 218 configured to releasably attach to the syringe body.
[0024] The knob 202 can rotate relative to the connector body 204 in discrete steps. In some aspects, the knob 202 may be part of a ratchet assembly to facilitate movement of the knob 202 relative to the connector body 204 in one rotational direction, but impede movement in the opposite rotational direction. The knob 202 may include a flexible arm 220, and the flange 216 of the connector body 204 may have an outer periphery with a plurality of radial grooves 222 defining teeth therebetween, such as... Figure 6 As shown. The flexible arm 220 may have a fixed end attached to the knob 202 and a free end with a radial protrusion 224 received in a radial groove of radial recesses 222. The flexible arm 220 may extend circumferentially about the longitudinal axis of the injection device 200 and be positioned in a circumferential slot 221 through the thickness of the knob 202. Rotation of the knob 202 relative to the connector body 204 may cause the flexible arm 220 to be radially deflected outward relative to the longitudinal axis, such that the radial protrusion 224 rides over teeth between radial grooves 222 on the outer surface of the flange 216. The number of radial grooves 222 may correspond to discrete steps of the advance needle 208. Although shown as having a single flexible arm 220, the injection device 200 may include any number of flexible arms 220 and corresponding sets of radial grooves 222 around the circumference of the knob 202. A predetermined force may be required to radially deflect the flexible arm 220 to release the radial protrusion 224 from the radial grooves 222. The predetermined force provides tactile feedback regarding the position of the knob 202 and prevents uncontrolled extension and / or retraction of the pin 208 due to continuous rotation. The flexible arm 220 may additionally or alternatively be configured to generate audible feedback of an elastic restoring force against a radial protrusion 224 that contacts, for example, the inner surface of a radial groove 222. Thus, the radial protrusion 224 provides controlled rotation of the knob 202 relative to the connector body 204 and extension and / or retraction of the pin 208, providing feedback to the user.
[0025] At least one rotating pin 230 may extend from the pin holder 206 through the connector body 204 and into at least one rotating slot 232 in the knob 202. The at least one rotating pin 230 rotatably secures the pin holder 206 to the connector body 204, and movement of the at least one rotating pin 230 in the at least one rotating slot 232 allows the pin holder 206 to translate longitudinally through the cavity 205 of the connector body 204 to achieve the extension of the pin 208. For example, the connector body 204 may have at least one elongated channel 234 having a longitudinal length and a transverse length, wherein the longitudinal length is greater than the transverse length. The longitudinal length may be four or five times the diameter of the at least one rotating pin 230, and the transverse width may approximate the diameter of the at least one rotating pin 230. Thus, the longitudinal length of the at least one elongated channel 234 allows for longitudinal translation of each rotating pin 230 relative to the connector body 204, and the transverse length of the at least one elongated channel 234 prevents relative rotational movement of each rotating pin 230 relative to the connector body 204. At least one rotating pin 230 may be formed as a separate component from the needle holder 206, and the needle holder 206 may include at least one needle holder slot 236 configured to receive at least one rotating pin 230. The dimensions of the at least one needle holder slot 236 may be designed to approximate the outer diameter of the at least one rotating pin 230 to secure the at least one rotating pin 230 to the at least one needle holder slot 236. The at least one rotating pin 230 may be secured to the interior of the needle holder 206 using an adhesive. However, in an alternative embodiment (not shown), the at least one rotating pin 230 may be integrally formed with the needle holder 206 as a one-piece component, for example by injection molding (omitting the at least one needle holder slot 236). As shown, at least one rotating pin 230 may include two rotating pins 230 on opposite sides of the needle holder 206 and the needle 208. At least one needle holder slot 236 may include two needle holder slots 236 on opposite sides of the needle holder 206, each needle holder slot receiving one of the rotating pins 230. At least one elongated channel 234 may include two elongated channels 234 on opposite sides of the connector body 204, each elongated channel receiving one of the rotating pins 230. At least one rotating channel 232 may include two rotating channels 232 on opposite sides of the knob 202. A seal 238 may be disposed between the pin holder 206 and the connector body 204 to seal the inner cavity 205 of the connector body 204 and allow linear movement of the pin holder 206. The seal 238 may be an elastic ring received in a circumferential channel 239 in the pin holder 206 and engaging the inner surface of the connector body 204.
[0026] At least one rotating slot 232 may have a variable longitudinal dimension around the circumference of the knob 202 to guide longitudinal translation of at least one rotating pin 230 as the knob 202 rotates relative to the connector body 204. In some embodiments, at least one rotating slot 232 may have a distal surface that forms multiple steps to allow the pin seat 206 to advance and / or retract in discrete increments. A spring 240 may apply a biasing distal force to at least one rotating pin 230 to abut the distal surface of at least one rotating slot 232. The spring 240 may be a helical coil spring. A sleeve 242 may be positioned around the connector body 204 and received within the cavity of the spring 240. The sleeve 242 may have a transverse distal wall 244 in the form of a circumferential distal flange positioned between the distal portion of the spring 240 and at least one rotating pin 230. The spring 240 may be compressed between the flange 216 of the connector 204 and the distal wall 244 of the sleeve 242. The distal wall 244 of the sleeve 242 can distribute the distal extension force applied by the spring 240 to at least one rotating pin 230. Therefore, the sleeve 242 can precisely slide and press at least one rotating pin 230 such that the uneven structure of the spring 240 does not affect the force distributed to the at least one rotating pin 230. The rotational position of the step relative to the at least one rotating pin 230 can correspond to the rotational position of the radial protrusion 224 relative to the radial groove 222 to perform controlled, stepwise advance of the needle 208. The step of at least one rotating slot 232 can be rotatably engaged by an angled surface or ramp to allow the needle seat 206 to retract against the bias of the spring 240 when the knob 202 is rotated in the opposite direction. For example, by rotating the knob 202 counterclockwise, the needle 208 can be moved outward and its effective length increased. The movement of the knob 202 can be five identical steps, each step advancing the needle 208, thereby increasing the effective length of the needle 208 by 0.1 mm. By rotating knob 202, spring 240 advances at least one rotating pin 230 to a new step in at least one rotating slot 232, and spring 240 continuously presses at least one rotating pin 230 against the step. Thus, needle seat 206 can be advanced to the height of the step, such that the new length of needle 208 withdrawing from connector body 204 corresponds to the rotational position of at least one rotating pin 230 relative to the step. The total outward movement of needle 208 can be approximately 0.5 mm. The needle movement can be precise to 0.015 mm. The needle advance in each step can be as small as 0.05 mm and as large as 0.2 mm, but is not limited to this range, and depends on the application and tissue characteristics, such as hardness, thickness, etc. Knob 202 can be rotated clockwise back to shorten the effective length of needle 208 in the same step. In some embodiments, injection device 200 may advance needle 208 only in the forward direction.
[0027] The connector body 204 can be longitudinally fixed inside the knob 202. The connector body 204 can be inserted into the inner cavity 203 of the knob 202 until the distal surface of the flange 216 engages the proximal surface of the edge 248 on the knob 202, as shown. Figure 4 As shown. Edge 248 may be defined by different diameters between a wider proximal portion and a narrower distal portion of knob 202, the wider proximal portion being configured to receive the distal portion of syringe body, the narrower distal portion being configured to be covered by cap 210. Upon insertion, at least one locking member 246 may engage the proximal surface of flange 216 to prevent connector body 204 from retracting proximally from knob 202. For example, a locking member 246 may be at least one locking pin 246 that inserts into hole 250 of knob 202, thereby entering cavity 203 of knob 202 to engage flange 216. Sufficient space and / or frictional contact may be provided between locking member 246 and edge 248 to allow connector body 204 to rotate within cavity 203 of knob 202. Additionally or alternatively, connector body 204 may be longitudinally secured to knob 202 by other mechanisms such as snap-fit engagement.
[0028] As further shown, the syringe 100 can be releasably attached to the injection device 200 via a rotatable connection. The injection device 200 may have a male Luer connector on a proximal portion 218 of the connector body 204, which is configured to engage a female Luer connector on the syringe tip 104. The male Luer connector may include external threads on the proximal portion 218 of the connector body 204, and the female Luer connector may include internal threads on the syringe tip 104, such as... Figure 4 As shown. However, the connector body 204 can be attached to the syringe tip 104 using other releasable and / or secure attachment mechanisms. When connected, the inner portion of the syringe tip 104 can be inserted into the inner cavity 205 of the connector body 204 to position the chamber 108 of the syringe body in fluid communication with the inner cavity 207 of the needle hub 206 and the needle 208. When connected to the connector body 204, the inner cavity 203 of the knob 202 can receive the syringe tip 104 to provide additional stability.
[0029] Cap 210 can be releasably attached to knob 202 to close one or more distal portions of one or more of the distal portions of knob 202, connector body 204, and / or pin 208. Cap 210 may include one or more inner ribs 258 configured to receive (e.g., snap into) one or more outer recesses 252, 253 on knob 202 to longitudinally secure cap 210 to knob 202. One or more recesses 252, 253 may extend circumferentially around knob 202. Cap 210 may include at least one protrusion 254 extending from a proximal portion, and knob 202 may include at least one opening 256 in edge 248 configured to receive protrusion 254 to rotatably secure cap 210 to knob 202. Figure 3 As shown, the cap 210 may include a plurality of (e.g., two) protrusions 254, and the knob 202 may include the same number of openings 256. At least one protrusion 254 may extend longitudinally such that it can be inserted into at least one opening 256 when the cap 210 is received over a distal portion of the knob 202. At least one protrusion 254 may be configured to extend into the cavity 203 of the knob 202 and be received into at least one channel 226 (e.g., two channels 226) in the outer periphery of the flange 216 of the connector body 204, as... Figure 6 As shown.
[0030] Therefore, the cap 210 may have a first proximal position in which the inner rib 258 is received in the first groove 252, such as Figure 4As shown. In a first position, at least one protrusion 254 extends through at least one opening 256 and into at least one channel 226, thereby rotatably securing the cap 210, knob 202, and connector body 204. Rotational securing allows the injection device 200 to be tightened to the syringe 100 by rotation, thereby sealing the connection between the connector body 204 and the syringe 100 by means of preload between the Luer threads. When the cap 210 is in the first position, the connection between at least one protrusion 254, at least one opening 256, and at least one channel 226 enables the transmission of torque to apply preload to these components, thereby preventing undesirable rotation of the knob 202 before the connector body 204 is fully tightened onto the syringe 100. The cap 210 may have a second position distal to the first position, in which the inner rib 258 is received in a second recess 253. In the second position, at least one protrusion 254 still extends through at least one opening 256, thereby rotatably securing the cap 210 and knob 202. However, at least one protrusion 254 can be pulled to the distal side of at least one channel 226, thereby allowing relative rotation between the cap 210 / knob 202 and the connector body 204. A second position of the cap 210 allows the needle 208 to be advanced while still covered, thus preventing accidental punctures or contamination. In some embodiments, it is conceivable that the inner protrusion 258 on the cap 210 could instead be a groove, and the first groove 252 and the second groove 253 on the knob 202 could instead be a protrusion. Thus, the first position of the cap 210 can be defined by the inner rib or groove 258 of the cap 210 engaging with the first groove or rib 252 of the connector body 204, and the second position of the cap 210 can be defined by the inner rib or groove 258 of the cap 210 engaging with the second groove or rib 253 of the connector body 204. The cap 210 can then be removed from the knob 202 to insert the needle 208 into the tissue. In some embodiments, the knob 202 may include an elongated slot or window (not shown), and the connector body 204 may include multiple markings (e.g., numbers, not shown) indicating the depth of the pointer 208, such that rotation of the knob 202 relative to the connector body 204 selectively displays markings indicating the current depth of the pointer 208 to the user.
[0031] Figure 8 A flowchart of a method 500 for assembling an injection device 200 is shown.
[0032] In step 502, the needle 208 may be inserted into the cavity 207 of the needle holder 206 and secured to the needle holder 206. The needle 208 may be secured to the needle holder 206, for example, with an adhesive. The seal 238 may be assembled to the needle holder 206, for example, by insertion into the circumferential channel 239.
[0033] In step 504, the pin header 206 can be inserted into the connector body 204. When inserted, the seal 238 can extend between the pin header 206 and the connector body 204 to provide a fluid-tight interface.
[0034] In step 506, the pin header slots 236 and elongated channels 234 can be aligned. Alignment can be performed using a tool (not shown) inserted into a slot (not shown) in the proximal portion of the pin header 206. For example, the slot may have a straight or cross-shaped shape, and the tool may accordingly have a flat-head or Philips-head end actuator, enabling rotation of the pin header 206 and / or connector body 204 to facilitate alignment. A rotating pin 230 can then be inserted into the elongated channels 234 and pin header slots 236 to rotatably secure the connector body 204 and pin header 206.
[0035] In step 508, the spring 240 and sleeve 242 can be assembled onto the connector body 204. The spring 240 can be inserted above the sleeve 242 and abut against the distal wall 244. The connector body 204 can be inserted into the cavity of the sleeve 242 such that the spring 240 and sleeve 242 are positioned on top of the rotating pin 230, and the distal wall 244 of the sleeve 242 contacts the rotating pin 230.
[0036] In step 510, the connector body 204, spring 240, and sleeve 242 can be assembled into the cavity 203 of the knob 202. The connector body 204 can be inserted into the knob 202 until the distal surface of the flange 216 engages the proximal surface of the edge 248 on the knob 202. During insertion, the rotating pin 230 can be inserted into the rotation channel 232 to provide a rotational connection between the knob 202 and the connector body 204. However, in some embodiments, after the connector body 204 is assembled into the cavity 203 of the knob 202, the rotating pin can be simultaneously inserted into the pin seat slot 236, the elongated channel 234, and the rotation channel 232.
[0037] In step 512, the connector body 204 can be longitudinally secured inside the knob 202. For example, at least one locking pin 246 can be inserted into the knob 202 to longitudinally secure the connector body 204 inside the knob 202. The at least one locking pin 246 can be inserted into the hole 250 and contact the proximal portion of the flange 216. The at least one locking pin 246 allows the knob 202 to rotate relative to the connector body 204 but prevents the connector body 204 from retracting proximally. In some embodiments, the function of the at least one locking pin 246 can be replaced by other mechanisms, such as a snap-fit engagement.
[0038] In step 514, the cap 210 can be assembled onto the knob 202. The protrusion 254 can be inserted into the opening 256 and the channel 226 to rotatably secure the cap 210, knob 202, and connector body 204 in a first position. The cap 210 can be retracted into a second position and / or removed during use.
[0039] Although the systems and methods have been described with reference to various embodiments in conjunction with multiple figures, those skilled in the art will understand that changes can be made to the embodiments without departing from their broad inventive concept. Therefore, it should be understood that this disclosure is not limited to the specific embodiments disclosed, but is intended to cover modifications within the spirit and scope of this disclosure as defined by the claims.
Claims
1. An injection device, the injection device comprising: A connector body configured to be releasably attached to a syringe; The needle attached to the needle holder; and A knob configured to rotate relative to the connector body to advance and / or retract the pin socket.
2. The injection device of claim 1, wherein the knob is configured to advance and / or retract the needle hub in discrete steps.
3. The injection device according to claim 1, further comprising: At least one pin connects the needle holder and the knob. The knob includes at least one rotating slot for receiving the at least one pin, and the at least one pin rotatably secures the pin seat relative to the connector body.
4. The injection device of claim 3, wherein the at least one rotating slot includes a distal surface that forms a plurality of steps to enable the needle hub to advance and / or retract in discrete steps.
5. The injection device of claim 4, wherein the plurality of steps are connected to angled surfaces to allow retraction of the needle.
6. The injection device of claim 3, further comprising a spring configured to bias the at least one pin distally within the at least one rotating slot.
7. The injection device of claim 6, further comprising a sleeve received within the cavity of the spring, wherein the sleeve has a distal sidewall disposed between the spring and the at least one pin.
8. The injection device of claim 1, wherein the knob includes a flexible arm with a radial protrusion, the connector body includes a flange with a plurality of radial grooves, and for each of the discrete steps, the radial protrusion is received in one of the radial grooves.
9. The injection device according to claim 1, wherein the connector body is longitudinally fixed to the knob.
10. The injection device of claim 9, further comprising at least one locking member, wherein the connector body includes a flange, and the at least one locking member engages the flange to prevent the connector body from retracting proximally from the knob.
11. The injection device of claim 1, wherein the connector body has a proximal portion including a first Luer connector configured to releasably attach to a second Luer connector on a distal portion of the syringe.
12. The injection device of claim 1, wherein the connector body includes a cavity configured to receive a tip on a distal portion of the syringe, and the knob includes a cavity configured to receive the distal portion of the syringe.
13. The injection device according to claim 1, wherein the injection device further comprises an elastic ring between the needle seat and the connector body.
14. The injection device according to claim 1, further comprising a cap disposed above the distal portion of the knob.
15. The injection device of claim 14, wherein the cap is configured to be rotatably fixed to the knob upon attachment, such that rotation of the cap causes rotation of the knob.
16. The injection device of claim 15, wherein the cap includes at least one protrusion, and the knob includes at least one opening configured to receive the at least one protrusion to rotatably secure the cap to the knob.
17. The injection device according to claim 16, The cap has a first position in which the at least one protrusion extends through the at least one opening and into at least one channel of the connector body, thereby rotatably securing the cap, the knob, and the connector body. The cap has a second position in which the at least one protrusion extends through the at least one opening, thereby rotatably securing the cap and the knob and allowing relative rotation of the cap relative to the connector body.
18. The injection device of claim 17, wherein the first position is defined by an inner rib or groove of the cap that engages with a first groove or rib of the connector body, and the second position is defined by an inner rib or groove of the cap that engages with a second groove or rib of the connector body.
19. A system comprising: The injection device as described in at least one of the preceding claims; and A syringe that can be releasably attached to the injection device.
20. A method for assembling an injection device according to at least one of the preceding claims, the method comprising: Secure the needle to the needle holder; The pin header is assembled into the connector body; The at least one rotating pin is inserted into the at least one rotating slot to rotatably secure the pin seat to the connector body; Assemble the spring and the sleeve onto the connector body; Assemble the connector body into the knob; The connector body is longitudinally fixed inside the knob; as well as Assemble the cap onto the knob.
